Verification & Testing Strategies For Compliance With ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1
This webinar will cover the following topics:
- What types of medical devices will require verification testing, and how to identify what standards your device needs to test to.
- Key aspects of these internationally recognized industry standards by explaining them in a simplified fashion.
- Review best practices and common mistakes for IEC 60601 testing for electrical medical devices.
- Provide details on the requirements for medical devices containing software and software as a medical device (SaMD) to show compliance to 62304/82304.
- Discussion of how best to capture internal verification testing based on FDA guidance for test protocols and reports.
- Review of how using a design traceability matrix is essential to ensuring all required testing is completed.
- Q&A session
Kyle Rose | Founder/President: Rook Quality Systems
Kyle is a Medical Device expert specializing in the development of efficient Quality Systems for small and startup medical device companies. Kyle founded Rook Quality Systems in 2012 to enable clients to implement compliant Quality Management Systems (QMSs), and to ensure that clients can efficiently produce effective and reliable medical devices, Rook has been overseeing overall quality strategy and ensuring compliance through documentation and auditing services for nearly a decade.
Kyle is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA. Kyle encourages the simplification of Quality Systems to reduce the quality burden and to improve compliance through training and efficient QS design.