The R&Q Intelligence Tour brings some of the medical device industry's leading experts direct to you-including notified body and technical committee representatives. We’ll discuss changing regulations and present actionable recommendations for next steps, along with examining other critical industry trends.
Date: Thursday, May 4, 2017
Time: 1:00pm – 4:15pm
Agenda
1:00pm - 2:00pm - ISO 13485:2016
Presented by R&Q Director of Minnesota Operations / Principal Consultant - and ISO Technical Committee 210 (TC210) and Working Group 1 (WG1) member - Mark Swanson. This session outlines how organizations should establish a risk-based approach as outlined in the requirements of ISO 13485:2016, and the changes associated with implementation of the new edition of ISO 13485. In this session, we will establish a basic understanding of the application of the risk-based approach in your QMS process, the evidence that will show this implementation to auditors, and how these are implemented in your update to your QMS.
2:00pm - 3:00pm - MDSAP
MDSAP can potentially offer a variety of important advantages. While currently optional for FDA, it will be mandatory for Health Canada in January of 2019. Times will be busy with limited qualified registrars, ISO 13485:2016 implementation by March 2019, and EU MDR by 2020. You will leave this session understanding MDSAP inside and out and be sufficiently prepared. Having been on the receiving end of two MDSAP audits, Connie Hoy of Cynosure Inc. (recently acquired by Hologic) will describe her successful first-hand experiences and offer step-by-step practical advice on how to adequately prepare for MDSAP and be successful. Her recent real-world case studies provide the perfect examples of what to do and how to accomplish it.
3:00 - 3:15pm BREAK
3:15pm - 3:45pm - Case for Quality
The Case for Quality has transformed into a movement for quality beyond compliance. This important initiative between the FDA and medical device industry has moved past the metrics and competencies of quality professionals into maturity models and data analytics that will drive the value proposition of medical devices. Come and hear an update from industry professionals and what you can do in preparation for the next steps coming in this important industry collaboration.
3:45pm - 4:15pm - Cybersecurity
The regulations at the federal level mandate that healthcare organizations, financial institutions, and federal agencies should protect their systems and information. Presented by R&Q Senior Principal Consultant Marilyn Waxberg, this session will outline the regulations and FDA guidance that shape cybersecurity, and outline the management of cybersecurity throughout the lifecycle of the product.
Who Should Attend?
Regulatory and Quality Staff
Medical Device Development and Manufacturing
Don't miss the Spring Social!
Life Sciences Pennsylvania's Spring Social is an annual gathering of approximately 300 life science professionals for relaxed, casual networking and connecting. In conjunction with the R&Q event LSPA is happy to offer $10 off your Spring Social Ticket. The Spring Social has been rated as Life Sciences Pennsylvania's top networking opportunity of the year. Make the most of your day and go directly from the R&Q education event to the Spring Social. For more information on exhibiting at the Spring Social contact Melissa Irwin [email protected].
