In early 2016, ISO finalized its latest version of the ISO 13485 standard for Medical Device Quality Systems. The first revision in over a decade, it revises ISO 13485:2003, including the 2009 Corrigendum and the application Guidance, ISO/TR 14969:2004. While there is a three year transition, there are some significant changes companies will need to consider as they plan for future documentation and integration.
During this 1-hour webinar, our expert team will cover these key topics and more:
- Significant changes
- Compare the old & new- Risk, Risk, Risk
- How ISO 9001 fits in - Annexes A and B
- The impact for compliance
You will have an opportunity to ask questions live.
Questions? Contact UL at [email protected]
Linda Chatwin, RAC, JD. – UL LLC
Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the regulatory maze required to bring products to market. She holds a Regulatory Affairs Certification and is an attorney in the U.S. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. Currently, she heads the North American Advisory Services group for UL, LLC, assisting clients with regulatory issues and challenges, including implementation of UDI processes. Ms. Chatwin travels worldwide to speak about changing market access issues.
Walt Murray, MasterControl
Walt Murray is a quality management and regulatory affairs professional with more than 32 years of experience working with internationally recognized, highly regulated companies, including Aventis-Pasteur, Merck, Pfizer, Stryker, USANA and Del Monte Foods. A Six Sigma Black Belt, Murray is certified in quality and environmental systems auditing (AQS Systems), critical-thinking skills and process control. He also has extensive training and consulting expertise in quality event/CAPA management, risk management, supplier control and audit management.
Having personally performed more than 200 third-party audits, for a variety of Fortune 500 life sciences companies, Murray has hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada.