For today’s medical device projects, the introduction of increasingly stringent Quality Management Standards such as ISO 13485 has necessitated testable requirements documentation that is clearer and more formalized than ever before.
In this small-group live tutorial, we’ll explore how to automate checklists for streamlining the authoring process of Product Requirements Documentation of Class 2+ medical devices – while satisfying best practices & compliance standards. Highlights include:
- Streamlining Verification and Validation by proactive automated analysis to achieve complete, testable, and measurable requirements.
- Generate a paper trail for Quality Management Systems that demonstrate the project’s hardware and software integration is accountable to the standards necessary for compliance.
- Enforce consistency of terminology from different stakeholders, suppliers, and standards that encompass human factors, environmental considerations, sterilization, biocompatibility, cybersecurity, and much more.