Qualio Design Controls unites your team’s systems in your QMS, making Qualio the single source of truth for all of your product development activities. Design Controls is built on ISO 14971, in harmony with ISO 13485 and CFR 820. The platform surfaces quality and safety impacts and produces output documentation in one click, so your medical device team can focus on building great products.

Challenge

Within Medical Device companies, Quality teams work within one system, and Product teams work within another. Those systems often do not speak to one another.

Siloed teams and systems make traceability and compliant releases impossible to manage. Without a single source of truth, work grinds to a halt, opening teams to risk and hindering innovation.

Solution

Qualio Design Controls unites your team’s systems in your QMS, making Qualio the single source of truth for all of your product development activities.

Design Controls enables end-to-end traceability and ISO 14971 and FMEA risk assessment, allows you to easily identify gaps, and generates your release documentation with one click.

Webinar - Design Controls Workflow for Medical Devices

Learn how medical device teams can use Design Controls throughout product development to assemble requirements and testing, track risks, and review & approve changes.

What you'll learn:

  • When and how Design Controls will be help Product Development teams during the different phases of development.

  • How Design Controls works in tandem with Qualio Docs

  • How to create design elements in Design Controls like User Needs, Design Inputs, Design Outputs, Risks, Validation and Verification records.

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