R&Q Regulatory and Quality Intelligence Tour: Critical Updates 2017
Date and Time
Tuesday, June 13th, 2017
8:00 AM - 4:00 PM CDT
1500 Park Place Blvd
Minneapolis, MN 55416
Drinks on R&Q across the street!
1665 Park Place Blvd
St Louis Park, MN 55416
MEMBERS & NON-MEMBERS: Free
The R&Q Intelligence Tour brings some of the medical device industry's leading experts direct to you – including FDA (invited), 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.
8:00 - 8:30 AM – Breakfast and Registration
8:30 - 8:35 AM – Welcome and Introduction
8:35 - 9:45 AM - ISO 13485:2016 – Mark Swanson, ISO Technical Committee 210 and Working Group 1 member, Director of Minnesota Operations, Regulatory and Quality Solutions (R&Q)
Outline of 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. Learn 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
9:45 - 10:00 AM - BREAK
10:00 - 11:00 AM – MDSAP – Connie Hoy, EVP of Regulatory Affairs and Clinical Development, Cynosure, Inc. + FDA invited from MDSAP program
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.
11:00 - 12:00 PM - Case for Quality
This session will be presented by former FDA/CDRH (Recent) Office of Device Evaluation. Name to be announced soon!
The Case for Quality has transformed into to 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. Industry professionals will discuss what you can do in preparation for the next steps coming in this important industry collaboration.
12:00 - 1:00 PM - Lunch
1:00 - 2:00 PM – EU MDR – Ibim Tariah, BSI
The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules. The time to plan and act on these changes is now. Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more will be affected. Plus new requirements are coming into play, including Eudamed and periodic safety update reports (PSURs). This session will describe what to do now, what to keep your eye on, and real-world examples that show how industry is working through the changes. Interpretations will evolve, but this session will absolutely help you navigate the process.
2:00 - 3:00 PM – MEDDEV 2.7/1 – BSI representative
Be prepared for the new requirements of MEDDEV 2.7.1 Rev 4. The grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision. Furthermore, the European Medical Devices Regulation (MDR) will impact CERs as well once the regulation comes into force. It is important to be proactive to ensure CERs will meet your notified body expectations. We will discuss the key changes and additional CER content required so that you can ensure your CERs are in compliance with MEDDEV Rev 4. Looking ahead to MDR enforcement, we will also discuss how the new regulations impact your CERs. Finally, we'll look at the common mistakes manufacturers make and how to avoid them, suggestions from a Notified Body perspective, and case studies of the most common problems related to Rev 4.
3:00 PM - Drinks on us! Discussion and Networking
Enjoy two drinks right across the street at Yard House on us! Thought leader discussion and networking reception, Q&A, and closing remarks - please join us! Two drink tickets per person will be offered.
Mark Swanson, Director of MN Operations, R&Q
Mark is R&Q's Director of Minnesota Operations / Principal Consultant - and is also a member of ISO Technical Committee 210 (TC210) and Working Group 1 (WG1). Additionally, he is a member of the MDIC Case for Quality Forum. Mark (CMQ/OE, CQE, CBA) has spent more than four years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 that was published on March 1, 2016 and has also participated with ISO TC176, WG24 on ISO 9001:2015. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single quality management system.
Ibim Tariah, Technical Director, BSI
Dr. Tariah has over 24 years experience in the medical device industry leading global organizations in successful product development, project management and product expertise. Dr. Tariah has been providing expertise in Vascular, Orthopaedic and Dental, and other long-term implantable devices for clients needing technical documentation assessment and reviews. His vast experience includes regulatory knowledge of combination devices incorporating biologics, drugs and drug-biologics. He also acts as a liaison with Regulatory Authorities including MHRA, European Medicines Agency (EMA), Medical Products Agency (Sweden), FDA, Health Canada and Therapeutic Goods Administration (TGA).
Connie Hoy, SVP of Global RA and QA, Cynosure
Having been on the receiving end of two MDSAP audits, special R&Q Intelligence Series guest 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.