On January 31, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule amending the longstanding Quality System Regulation (QSR, 21 CFR Part 820), introducing the Quality Management System Regulation (QMSR) effective February 2, 2026.
This shift represents a pivotal harmonization with the international standard ISO 13485:2016, aiming to streamline global compliance while retaining essential U.S.-specific safeguards. Recognizing the implications for our customers, we proactively updated our core medical device template documents, including procedures for design controls, supplier management, risk assessment, and corrective actions, to align with these new requirements. This forward-thinking update ensures seamless integration by the enforcement date, minimizes disruptions, and positions our customer to leverage the QMSR's emphasis on risk-based thinking and efficiency.
At its core, the transition from QSR to QMSR replaces much of the outdated QSR framework spanning Subparts C through O with a direct incorporation of ISO 13485:2016, fostering a more holistic quality management approach. Key enhancements include a stronger focus on risk management across the entire product lifecycle (beyond QSR's design-validation limits), mandatory documented supplier qualification and performance monitoring, and bolstered corrective and preventive action (CAPA) systems with trend analysis and effectiveness checks.
Additionally, the QMSR eliminates previous exemptions for internal records like management reviews and audits, making them fully accessible to FDA inspections, while introducing U.S.-tailored provisions for complaint handling, device labeling, unique device identification (UDI), and medical device reporting to uphold domestic oversight. These changes, though additive in some areas, promise reduced redundancy for manufacturers operating internationally and clearer pathways for continuous improvement.
By embedding these updates into our quality template documents now, we're not only safeguarding regulatory adherence but also empowering you with modern tools for agility and excellence. As the 2026 deadline approaches, we encourage quality leaders to assess their QMS portfolios and make the necessary updates. Early action today translates to stronger outcomes tomorrow. The following provides a deeper dive into the specific document revisions:
Document Title | Revision Update |
HW HWSaMD HSW27001 IVD COMBO Quality Manual | The Quality Manual has been revised to incorporate the new FDA QMSR requirements, including additional details on the Design History File, Technical File, post-market surveillance, adverse event reporting, and product recall procedures. The management review process has also been enhanced to include a more comprehensive review of quality performance data. |
SaMD Quality Manual | The Quality Manual has been comprehensively reviewed and revised to align with the latest FDA Quality Management System Regulation (QMSR) requirements. Key updates include enhanced sections on design controls, device history documentation, and post-market surveillance. |
HW HWSaMD HSW27001 COMBO SaMD IVD SaMD27 General Change Procedure | Updating the change control procedure to align with the latest FDA QMSR requirements. Key changes include: - Expanded guidance on design changes, process changes, and changes to quality/regulatory records - Requirement to document a comprehensive impact assessment, including identification of all affected processes and systems - Requirement to perform a risk assessment for the proposed change and document mitigation strategies - Clarification of the roles and responsibilities for change management activities |
HW HWSaMD HSW27001 COMBO IVD SaMD SaMD27 Document Control | The document has been revised to align with the FDA's QMSR requirements, incorporating risk-based decision-making, defining Top Management responsibilities, and strengthening document versioning and archiving processes. |
HW HWSaMD HSW27001 IVD COMBO SaMD SaMD27 Risk Management | The document has been revised to align with the latest FDA Quality Management System Regulation (QMSR) requirements, including references to 21 CFR 801 (Labeling), 21 CFR 830 (Unique Device Identification), and other relevant sections. The update provides more detailed guidance on the risk management process and its integration into the organization's quality management system. |
HW HSW27001 HWSaMD IVD COMBO, SaMD SaMD27 Control of Quality, Regulatory and Product Records | The current version of the document has been updated to provide more comprehensive guidance on the creation, implementation, review, and storage of quality, regulatory, and product records to ensure compliance with applicable regulatory requirements. The scope of the procedure has been expanded to cover a wider range of records, and the responsibilities for generating, managing, and approving the records have been clearly defined. |
HW HSW27001 HWSaMD IVD SaMD SaMD27 COMBO Training | The training procedure has been updated to align with the latest FDA Quality Management System Regulation (QMSR) and EU Medical Device Regulation (MDR) requirements. The scope has been expanded to ensure training covers SaMD/IVD-specific processes and combination product cGMP requirements. The responsibilities section has been updated to clarify the roles of Quality Assurance, Managers, and all staff in determining, performing, and documenting training. The training plan creation and assignment process has been clarified, with a focus on risk-based prioritization of critical roles and activities. |
HW HSW27001 HWSaMD COMBO IVD SaMD27 SaMD Management Review | The management review procedure has been updated to align with the latest regulatory requirements, including the FDA Quality Management System Regulation (QMSR) and the EU Medical Device Regulation (MDR). The key changes include: - Expanded management review inputs to include a more comprehensive review of post-market surveillance activities, device tracking, medical device reporting, and other critical quality and regulatory inputs. - Emphasis on the use of a risk-based approach to prioritize management review actions based on the severity and probability of risks to patient safety and product quality. - Enhanced documentation and traceability requirements for management review records to ensure availability during regulatory inspections. |
HW HSW27001 HWSaMD COMBO IVD SaMD SaMD27 Design Controls | The procedure has been revised to align with the latest FDA Quality System Regulation (QMSR) requirements, including specific references to 21 CFR 820 regulations. The scope has been expanded to include software as part of the medical device, with references to the software development process. The risk management activities have been better integrated throughout the design and development process, in alignment with ISO 14971 requirements. The design review process has been clarified, with specific requirements for participant roles and documentation of action items. |
HWSaMD HW HSW27001 COMBO SaMD SaMD27 IVD Validation of Software and Spreadsheets | The procedure has been revised to align with the new FDA Quality Management System Regulation (QMSR) under 21 CFR Part 820 and the EU/UK Medical Device Regulation (MDR) requirements. Key updates include: - Expanded scope to cover software and spreadsheets that impact regulatory compliance - Incorporation of SaMD and IVD-specific validation requirements, including cybersecurity and conformity assessment - Alignment of responsibilities to ensure SaMD/IVD validation is addressed - Updated references to the latest regulations, standards, and guidance documents |
HW HWSaMD HSW27001 COMBO IVD SaMD SaMD27 Purchasing and Supplier Controls | The procedure has been updated to align with the latest FDA Quality Management System Regulation (QMSR) requirements under 21 CFR Part 820, as well as incorporate additional requirements from international regulations and standards such as the EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR). |
HWSaMD HW COMBO IVD SaMD SaMD27 Corrective and Preventive Action (CAPA) | The CAPA procedure has been revised to align with the latest FDA Quality Management System Regulation (QMSR) requirements, including provisions for medical device reporting, reports of corrections and removals, unique device identification, and electronic records compliance. The scope, responsibilities, and procedural steps have been updated to strengthen the CAPA process and ensure it effectively addresses safety, performance, and regulatory requirements. |
HW HWSaMD HSW27001 COMBO IVD SaMD SaMD27 Non-Conformance Management | Revising the document to enhance alignment with FDA's Quality System Regulation (QMSR) requirements, including updates to the nonconformity grading system, supplier NCR controls, UDI and labeling requirements, regulatory reporting, and records management. |
HW HSW27001 HWSaMD COMBO IVD SaMD SaMD27 Internal Quality Audits | The document has been revised to align with the FDA's new Quality Management System Regulation (QMSR) and to include additional requirements for auditing UDI, labeling, and combination product compliance. |
SaMD HWSaMD SaMD27 HSW27001 COMBO Software System Verification and Validation | The document has been revised to align with the latest FDA Quality Management System Regulation (QMSR) requirements and to provide more detailed guidance on the risk-based approach to software verification and validation. |
SaMD HWSaMD HSW27001 COMBO SaMD27 Software Validation Procedure (IQ/OQ/PQ) | The procedure has been revised to align with the latest FDA Quality Management System Regulation (QMSR) requirements and incorporate additional validation activities for combination products, Unique Device Identification (UDI), and Software as a Medical Device (SaMD). |
SaMD COMBO SaMD27 HSW27001 HWSaMD Software Development Processes | The procedure has been updated to incorporate the latest regulatory requirements, including alignment with the FDA's new Quality Management System Regulation (QMSR). Key changes include: - Expanded scope to cover contracted software development and off-the-shelf (OTS) software used in medical devices or quality systems - Clarified responsibilities to require training and competence for all personnel involved in design, development, verification, and validation - Strengthened risk management process with detailed requirements for software safety classification per IEC 62304 - Added requirements for design outputs to include tests to verify compliance with labeling and UDI requirements - Requirement to maintain all design and development records for inspection |
SaMD SaMD HWSaMD COMBO HSW27001 SaMD27 Software Standard Coding Practices | The document has been revised to align with the latest FDA QMSR requirements, expand the scope to cover all regulated software, and incorporate additional regulatory and cybersecurity considerations. |
HW HSW27001 HWSaMD COMBO IVD Analysis of Data | The procedure has been updated to provide more detailed guidance on data analysis methods, including the use of statistical techniques and integration with risk management processes. The responsibilities section has been clarified, and new sections have been added to address the analysis of UDI, combination product, and cybersecurity data. |
HW IVD HSW27001 HWSaMD COMBO Statistical Techniques | The document has been comprehensively reviewed and updated to align with the latest FDA QMSR requirements, expand the scope of statistical techniques, and enhance the guidance on responsibilities and data analysis methods. |
HW COMBO HSW27001 HWSaMD IVD Customer Communications and Feedback | The procedure has been updated to align with the latest FDA quality management system regulation (QMSR) requirements. Key changes include: - Expanded scope to cover all product types (hardware, SaMD, IVD, combination products) - Enhanced responsibilities for Quality Assurance oversight - Inclusion of additional feedback sources (UDI, reportable events, cybersecurity, usability) - Clarification of electronic records management requirements |
HW COMBO HSW27001 HWSaMD IVD Customer Complaints | The procedure has been updated to align with the FDA's new Quality Management System Regulation (QMSR) requirements, including specific provisions for combination products, software as a medical device (SaMD), and cybersecurity. The scope, responsibilities, and references have also been expanded to ensure the complaint handling process is compliant with the latest regulatory expectations. |
HW HSW27001 HWSaMD IVD COMBO Medical Device Adverse Event Reporting, Vigilance, and Incident Reporting | The document has been reviewed and updated to align with the FDA's new QMSR requirements. Key changes include: - Expanded responsibilities for Quality Assurance - New requirements for adverse event reporting related to UDI, cybersecurity, and SaMD usability - Updated references to include relevant FDA regulations and guidance, as well as international standards |
HW HSW27001 HWSaMD COMBO IVD Product Recall, Field Correction, and Advisory Notices | The procedure has been comprehensively reviewed and revised to align with the latest regulatory requirements, including the FDA Quality Management System Regulation (QMSR) 21 CFR Part 820, ISO 13485:2016, and other relevant standards and guidance documents. Key updates include: - Expanded responsibilities for the CEO, Director of Quality/Regulatory, and Recall Coordinator - Detailed notification requirements for regulatory authorities (FDA, Health Canada, EU/UK, Brazil, Japan, Australia) - Enhanced record-keeping and documentation procedures, including the use of validated software tools - Alignment with UDI and cybersecurity guidance for medical device recalls |
HW IVD COMBO HSW27001 HWSaMD User, Market, and Product Requirements | The document has been updated to incorporate the latest regulatory requirements and industry best practices for medical device design controls. Key changes include: - Expanded scope to address risk management, UDI, cybersecurity, and usability considerations - Clarified responsibilities for the Project Leader and Marketing team - Updated terms and definitions to align with current industry standards - Enhanced the procedure section to strengthen risk management, software validation, and traceability requirements - Expanded the references section to include the latest relevant standards and guidance |
HW COMBO HSW27001 HWSaMD IVD Design Verification and Validation | The document has been revised to align with the latest FDA QMSR requirements, incorporating additional standards and guidance for medical device design controls, risk management, software validation, and SaMD-specific considerations. |
HW IVD HWSaMD HSW27001 COMBO Process Validation Procedure | The process validation procedure has been comprehensively reviewed and updated to align with the latest FDA QMSR requirements, including the addition of new sections on risk management, SaMD-related process validation, and UDI compliance. |
HW COMBO HWSaMD HSW27001 IVD Device Master Record | The document has been revised to align with the FDA's new Quality Management System Regulation (QMSR) requirements for Device Master Records. Key updates include: - Expanded scope to include contract manufacturing - Clarified responsibilities for trained and competent personnel - Added new terms and definitions related to intended use and usability - Explicitly required inclusion of risk management, UDI, and software documentation in the DMR. |
HW COMBO HSW27001 HWSaMD IVD Product Identification and Traceability | The procedure has been updated to align with the FDA's new Quality Management System Regulation (QMSR) requirements, including expanded requirements for combination products, implantable and life-sustaining devices, and supplier traceability controls to ensure product integrity, prevent mix-ups, and mitigate risks associated with nonconforming products or field corrective actions. |
HW COMBO HSW27001 HWSaMD IVD Unique Device Identification | The document has been revised to clearly define the roles and responsibilities for the UDI process, including the Supply Chain Team, Product Managers, Regulatory Team, and Quality Assurance. The procedure for outsourced UDI labeling has been enhanced to include vendor qualification, data verification, and record-keeping requirements. Additionally, the process for maintaining and updating the GUDID and EUDAMED databases has been strengthened to include a formal review and change control process. The references section has been updated to reflect the latest versions of relevant regulations, standards, and guidance documents. |
HW COMBO HSW27001 HWSaMD IVD Production Work Environment | The document has been updated to incorporate risk-based approaches for infrastructure, work environment, and contamination control requirements to ensure compliance with FDA's Quality Management System Regulation (QMSR) for medical devices and combination products. |
HW COMBO HSW27001 HWSaMD IVD Production Work Order and Device History Record | The procedure has been updated to align with the requirements of the FDA's new Quality Management System Regulation (QMSR). Key changes include: - Clarifying the objective and scope to emphasize the importance of risk management and compliance with applicable requirements. - Enhancing the responsibilities to explicitly include Quality Assurance's role in reviewing and approving work orders and DHRs. - Adding the definition of Device Master Record (DMR) to the terms and definitions section. |
HW COMBO HSW27001 HWSaMD IVD Storage, Handling, and Distribution | The procedure has been revised to align with FDA's new Quality Management System Regulation (QMSR) requirements. Key changes include: - Expanded objective to emphasize product integrity, traceability, and compliance - Strengthened scope to include risk-based controls and CMO oversight - Clarified responsibilities of designated competent employees and Quality Assurance - Enhanced storage requirements for quality retention samples. |
HW HWSaMD HSW27001 COMBO IVD Receiving of Purchased Materials | The procedure has been updated to align with the FDA's new Quality Management System Regulation (QMSR) requirements. Key changes include: - Incorporation of risk-based inspection criteria and verification of compliance with DMR specifications and applicable regulatory requirements. - Expanded responsibilities for receiving and inspection personnel, including the requirement for training and competence. - Additional details on the inspection process, such as documentation of lot numbers/UDIs and labeling of accepted materials. |
HW COMBO HSW27001 HWSaMD IVD Equipment Calibration and Maintenance | The procedure has been updated to align with the latest FDA Quality Management System Regulation (QMSR) requirements. Key changes include: - Expanding the objective to explicitly address combination products and incorporate risk-based controls for critical equipment. - Clarifying the scope to include all equipment used in the manufacturing, testing, and storage of medical devices and combination products. - Emphasizing the risk-based approach to the calibration and preventive maintenance program in the responsibilities section. - Updating the terms and definitions to include the concept of 'critical equipment' whose failure could impact product quality or safety. |
HW COMBO HSW27001 HWSaMD IVD Technical Files & Regulatory Controls | The procedure has been updated to align with the latest FDA QMSR requirements and expand the scope to cover all medical devices, IVDs, and combination products designed, manufactured, or distributed by the organization. Key changes include: - Clarifying the objective and scope of the procedure - Explicitly defining the responsibilities of the Quality Assurance and Regulatory Affairs departments - Adding a new section on managing changes to the product or quality system, including notifying the Notified Body of substantial changes - Other minor updates to improve clarity and alignment with current regulatory requirements. |
HW COMBO HSW27001 HWSaMD IVD Labeling and Packaging | The procedure has been updated to provide more comprehensive guidelines on labeling and packaging requirements for medical devices, IVDs, and combination products. Key changes include expanded scope, enhanced responsibilities, detailed labeling design and validation requirements, and the addition of a record retention section. |
HW COMBO HSW27001 HWSaMD IVD Product Order and Shipping | The document has been comprehensively reviewed and revised to align with the latest FDA Quality Management System Regulation (QMSR) requirements, with a focus on ensuring compliance with customer and regulatory requirements, including Unique Device Identification (UDI), traceability, and labeling standards. The procedure has been updated to incorporate risk management principles throughout the order processing and shipping activities. |
HW COMBO HSW27001 HWSaMD IVD Final Acceptance Inspection | The final acceptance inspection procedure has been updated to: - Align with current FDA QMSR, EU MDR, and other regulatory requirements - Incorporate risk management principles and integrate UDI, traceability, and labeling compliance into the final inspection process - Provide more detailed criteria for classifying defects and defining appropriate sampling plans - Enhance the documentation and records required for the final product release. |
HW COMBO HSW27001 HWSaMD IVD Sterilization of Product | The document has been revised to align with the latest FDA Quality Management System Regulation (QMSR) requirements, ensuring the sterilization process and controls are compliant. The scope has been expanded to include in-vitro diagnostic (IVD) devices and integrate risk management principles, ensuring a comprehensive approach to product safety and performance. Responsibilities have been clearly defined, and additional references to relevant regulations have been included to ensure compliance with all applicable requirements. |
HW COMBO HSW27001 HWSaMD IVD Contamination of Product | The procedure has been reviewed and revised to provide a more comprehensive and risk-based approach to contamination control for medical devices, including IVD devices, in alignment with FDA's new Quality Management System Regulation (QMSR) requirements. The updates include enhanced scope, responsibilities, terms and definitions, as well as additional preventive measures and record-keeping requirements. |
HW COMBO HSW27001 HWSaMD IVD Post-Market Surveillance | The post-market surveillance procedure has been updated to align with the latest FDA Quality Management System Regulation (QMSR) requirements, as well as the EU Medical Device Regulation (MDR) 2017/745 and UK Medical Device Regulations (UK MDR) 2002. Key changes include: - Expanded scope to cover UDI, traceability, and labeling requirements, as well as controls for outsourced PMS activities. - Enhanced responsibilities to include the PRRC role in reviewing PMSR/PSUR reports and designated representatives for outsourced PMS. - Detailed updates to the PMS plan, data collection, and reporting sections to provide more clarity and align with regulatory expectations. |
HW COMBO IVD Validation Program | The document has been revised to align with the FDA's new Quality Management System Regulation (QMSR) requirements, expanding the scope of the validation program to cover all relevant facilities, processes, equipment, and software related to the manufacture of medical device products, including in-vitro diagnostic (IVD) devices. The updated program incorporates risk management, UDI, traceability, and labeling requirements to ensure consistent product quality, safety, and performance. |
HW HSW27001 HWSaMD IVD COMBO Clinical Evaluation Reporting (MDR) | The document has been updated to align with the latest regulatory requirements, including the integration of risk management and post-market clinical follow-up (PMCF) into the clinical evaluation process. The scope, responsibilities, and references have also been revised to provide more clarity and ensure compliance with the EU Medical Device Regulation (MDR) 2017/745 and related guidance documents. |
HW COMBO HSW27001 HWSaMD IVD Technical Files & Regulatory Controls (UK MDR) | The document has been thoroughly reviewed and revised to align with the latest regulatory requirements for medical devices to be sold in the United Kingdom. Key updates include expanded guidance on technical file and design dossier preparation, the roles and responsibilities of the EU Authorized Representative and UK Responsible Person, and the inclusion of additional relevant standards and guidance documents. |
HW COMBO HSW27001 HWSaMD IVD Deviation Management | The SOP has been revised to provide a more comprehensive approach to deviation management, including detailed procedures for planned and unplanned deviations. The objective and scope have been expanded to cover medical devices, drug products, IVDs, and combination products. The responsibilities and definitions have been clarified, and the procedure section has been reorganized and expanded to better address the various scenarios and requirements for deviation handling. |
SaMD HSW27001 HWSaMD IVD Customer Complaints | The procedure has been updated to align with the latest FDA QMSR requirements, expand the scope to cover customer/product complaints for all medical devices (including SaMD and IVD), clarify roles and responsibilities, and enhance the investigation and trending process to ensure risk-based evaluations and regulatory compliance. |
SaMD HSW27001 HWSaMD COMBO Adverse Event, Vigilance and Incident Reporting | The SOP has been comprehensively reviewed and revised to align with the latest FDA Quality Management System Regulation (QMSR) requirements. The scope, responsibilities, and procedural details have been updated to ensure the organization's adverse event reporting process is compliant across all medical devices marketed. |
SaMD SaMD27 HWSaMD HSW27001 COMBO User, Market, and Product Requirements | The document has been revised to align with the FDA's new Quality Management System Regulation (QMSR) requirements, expanding the scope to include software as a medical device (SaMD) and combination products. Responsibilities have been clarified, and the references section has been updated to include relevant FDA regulations and guidance. |
SaMD SaMD27 HWSaMD HSW27001 COMBO Technical Files & Regulatory Controls | The procedure has been updated to address the requirements of the FDA Quality Management System Regulation (QMSR) in addition to the EU Medical Device Regulation (MDR). Key changes include: - Expanded scope to include medical devices marketed in the United States - Clarified responsibilities for Quality Assurance in maintaining the Quality Management System - Updated terms and definitions to include additional lifecycle management concepts - Emphasized the importance of supplier controls to ensure compliance |
SaMD SaMD27 HSW27001 HWSaMD COMBO Product Recall, Field Correction, and Advisory Notices | The document has been thoroughly reviewed and updated to align with the FDA's new Quality Management System Regulation (QMSR) requirements. Key changes include: - Expanded the Scope section to explicitly exclude internal product disposition, process nonconformities, and risk management procedures, which are addressed under separate Quality System procedures. - Added a new section on Recall Coordinator responsibilities to ensure all recall activities are properly coordinated and documented in compliance with applicable regulations. - Revised the Records Retention section to specify a minimum 2-year retention period for all records associated with recalls, as required by the QMSR. |
SaMD SaMD27 HSW27001 HWSaMD COMBO Nonconformance Process | The document has been revised to enhance the nonconformance process and align it with current regulatory expectations for medical device quality systems. Key updates include: - Clarification of the purpose of the nonconformance process and its role in supporting compliance - Expanded responsibilities for Quality Assurance to ensure the process meets applicable regulatory requirements - Improved classification of nonconformances based on severity and potential patient safety impact - Requirement to document and retain all risk assessments as quality records. |
SaMD SaMD27 HWSaMD HSW27001 COMBO Design Controls | The procedure has been revised to align with the FDA Quality System Regulation (QMSR) requirements, including more detailed specifications for the Device Master Record. Additional updates have been made to integrate risk management activities per ISO 14971:2019 and to address usability engineering as per FDA guidance. |
SaMD SaMD27 HWSaMD HSW27001 IVD COMBO Development of Product Labeling | The document has been updated to align with the FDA's new Quality Management System Regulation (QMSR) requirements for medical device labeling. Key changes include: - Incorporation of requirements for risk assessment of labeling content during design review and validation of electronic labeling - Expansion of responsibilities to include periodic review of labeling activities and consideration of post-market labeling issues - Detailed guidance on the label change process, including the need to reference applicable CAPA or feedback records and assess the impact on existing product labels - Update of references to include the applicable sections of the FDA QMSR and Labeling regulation. |
SaMD SaMD27 HWSaMD HSW27001 COMBO Validation of Software and Spreadsheets | The scope of the software and spreadsheet validation procedure has been expanded to include cloud-hosted, mobile, and AI/ML-based applications. Cybersecurity requirements and controls have been added, and definitions for SaaS and SOUP have been included. The procedure has also been updated to address validation of Part 11 and Annex 11 controls, as well as requirements for evaluating SaaS/cloud providers. |
SaMD SaMD27 HWSaMD HSW27001 COMBO Product Identification, Traceability and Unique Device Identifier (UDI) Management | The document has been updated to: - Expand the scope to cover SaMD products distributed in other applicable regulatory jurisdictions beyond the US and EU. - Clarify the responsibilities of the Engineering, QA/RA, and IT teams in the SaMD UDI management process. - Provide additional details on the conditions for new DI and PI assignments, customer notification of updates, and the maintenance of GUDID and EUDAMED records. - Update the references section to include relevant SOPs for change management, risk management, and record control. |
SaMD SaMD27 HWSaMD HSW27001 COMBO Product Order Processing | The procedure has been updated to include the following key changes:
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SaMD SaMD27 HWSaMD HSW27001 COMBO Device Master Record | The Device Master Record (DMR) procedure has been updated to align with the latest FDA Quality Management System Regulation (QMSR) requirements under 21 CFR 820. Key changes include: - Added new sections on Unique Device Identification (UDI) and cybersecurity-related documentation for software as a medical device (SaMD), as applicable. - Clarified the responsibilities of the Design and Development team in providing and updating device specifications, design outputs, and risk management documentation for inclusion in the DMR. - Included a requirement for periodic review of the DMR after design transfers and when postmarket changes occur, such as Corrective and Preventive Actions (CAPA), complaints, and Postmarket Surveillance (PMS) outputs. - Extended the retention period for the DMR from 2 years post-release to the design and expected life of the device, in alignment with regulatory requirements. |
SaMD SaMD27 HSW27001 HWSaMD COMBO Clinical Evaluation Reporting | The document has been comprehensively reviewed and revised to align with the latest regulatory requirements, including the FDA's Quality Management System Regulation (QMSR) and the EU Medical Device Regulation (MDR) 2017/745. Key updates include: - Expanded scope to integrate risk management and conformity assessment aspects of the Clinical Evaluation Report (CER) - Enhanced responsibilities for senior management, design/risk/regulatory teams, and post-market surveillance in the CER process - Refined terminology and definitions to align with regulatory expectations - Strengthened requirements for consistency between clinical data, risk assessments, labeling, and instructions for use - Expanded references to include relevant standards and regulations (e.g., ISO 14971, FDA QMSR, 510(k), UDI) |
SaMD SaMD27 HWSaMD HSW27001 COMBO Post-Market Surveillance | The Post-Market Surveillance (PMS) procedure has been comprehensively reviewed and updated to ensure alignment with the latest regulatory requirements, including FDA QMSR and EU MDR. Key changes include: - Expanded scope to cover data collection, analysis, reporting, and CAPA integrated with the DMR and risk management file - Clarified responsibilities, including a dedicated Post-Market Surveillance Team and PRRC role - Enhanced PMS plan requirements to address software performance, updates, and cybersecurity risks for SaMD - Strengthened reporting section to ensure compliance with PMSR and PSUR requirements, as well as regulatory reporting record-keeping. |
SaMD SaMD27 HWSaMD HSW27001 COMBO UK Technical Files and Regulatory Controls | The document has been reviewed and revised to include a new section for the impact assessment of the proposed changes. Additionally, the technical file and design dossier review process has been expanded to explicitly include the review of the risk management report, clinical evaluation report, post-market surveillance data, complaints, and CAPA records. The references section has also been updated to include the latest versions of the relevant standards. |
SaMD SaMD27 HWSaMD HSW27001 COMBO Purchasing and Supplier Management | The procedure has been comprehensively updated to align with the FDA's new Quality Management System Regulation (QMSR) under 21 CFR Part 820, incorporating more detailed requirements for purchasing of devices, components, and services, including those for Software as a Medical Device (SaMD). |
IVD Device Master Record | The 'IVD Device Master Record' procedure has been updated to align with the FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820. The changes include expanding the scope to cover HCT/Ps regulated as devices, clarifying the responsibilities, and enhancing the device specifications and labeling requirements to ensure compliance with the latest regulatory standards. |
IVD Post-Market Surveillance | The post-market surveillance procedure has been updated to align with the latest regulatory requirements, including the FDA's QMSR, 21 CFR 803, the EU Regulation 2017/746 (IVDR), and the UK Medical Device Regulations (UK MDR). The changes aim to strengthen the organization's post-market surveillance system and ensure comprehensive coverage of all applicable post-market activities. |
IVD Performance Evaluation Reporting | The document has been reviewed and revised to align with the FDA's new Quality Management System Regulation (QMSR) requirements. Key updates include: - Expanded the objective to reference the FDA QMSR in addition to the existing EU and Swiss regulations. - Clarified the scope to explicitly state the global regulatory requirements for the performance evaluation report. - Integrated risk management principles throughout the procedure to ensure device safety and effectiveness. - Expanded the references section to include additional relevant FDA regulations and standards. |
IVD External Audits | The procedure has been updated to include the following key changes:
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IVD Deviation Management | The document has been updated to align with the FDA's new Quality Management System Regulation (QMSR) requirements. Key changes include: - Expanded responsibilities for Senior Management to review significant or recurring deviations - Enhanced procedures for unplanned deviations, including escalation to Regulatory Affairs for deviations that may impact patient safety or device performance - Addition of references to relevant FDA regulations (21 CFR 803, 21 CFR 806) |
SaMD SaMD27 HWSaMD HSW27001 COMBO Software Hazard Traceability | The document has been updated to align with the FDA's new Quality Management System Regulation (QMSR) requirements under 21 CFR 820. Key changes include: - Expanded responsibilities to include Design & Development personnel - Requirement to review and update the hazard traceability matrix at major design reviews and prior to release - Mandate to document rationale for severity scoring in the Risk Management File - Strengthened procedures to verify effectiveness of mitigations and compliance of labeling as mitigation |
SaMD Production Work Environment (ONLY FOR STANDALONE SOFTWARE) | The document has been updated to include requirements for standalone software (SaMD) production environments, with a focus on ensuring cybersecurity and data integrity controls are in place. Key changes include expanding the scope, adding new definitions, and enhancing the procedures for production environment controls and design transfer to production. |
COMBO Product Return and Servicing | The procedure has been revised to align with the FDA's new Quality Management System Regulation (QMSR) requirements, expand the scope to include product servicing and integration with complaint handling and CAPA processes, and provide more detailed information on the classification of recalls in different regions. |
COMBO Technical Files & Regulatory Controls (EU MDR/IVDD/IVDR Only) | The document has been reviewed and updated to ensure continued alignment with the latest EU MDR/IVDD/IVDR regulatory requirements. No substantive changes were made to the content, as this document is focused solely on the essential regulatory requirements for these directives. |
Please reach out to your Customer Success Manager (CSM) or Quality Success Manager (QSM) for assistance. Thank you.