Critical Medical Device Updates 2017: Preparing for Global Regulatory Changes
Presented in partnership with R&Q and the Pittsburgh Technology Council
The R&Q Intelligence Tour in partnership with the Pittsburgh Technology Council brings you some of the industry's leading experts – including FDA (invited), Notified Body, and technical committee representatives. This one-day learning opportunity will cover ISO 13485:2016, MDSAP, Case for Quality, EU MDR, and MEDDEV 2.7/1. You will learn about changing regulations, critical industry trends, and be presented with actionable recommendations for next steps to help you meet the changes in regulatory compliance.
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.
As Senior FDA Compliance Principal at R&Q, Jake assesses medical device firms' compliance status, develop and supports response and remediation activities, and provides expert advice on management of specific compliance issues. Prior to joining R&Q in early 2016, Jake spent over 21 years as an FDA investigator / medical device specialist while based in Pittsburgh, PA. Jake has conducted over 400 FDA inspections, and spent the last two years assigned to FDA's dedicated medical device cadre for international operations. Prior to joining FDA Jake spent 12 years as a civilian employee of the U.S. Navy's Naval Air Warfare Center (aerospace engineer / program manager) . In this capacity Jake provided full spectrum engineering and technical program support relating to R,D,T&E and fleet support of naval aviation platforms. Jake holds a BS in Mechanical Engineering from the Pennsylvania State University.
Agenda (subject to slight change):
8:00 - 8:30 – Breakfast and Registration
8:30 – 8:35 – Welcome and Introduction
8:35 - 9:45am - ISO 13485:2016:
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.
Mark Swanson, ISO Technical Committee 210 and Working Group 1 member, Director of Minnesota Operations, Regulatory and Quality Solutions (R&Q)
9:45 - 10:00am - BREAK
10:00 - 11:00am – 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. Understand MDSAP inside and out and be sufficiently prepared. Successful first-hand experiences will be shared along with step-by-step practical advice on how to adequately prepare for MDSAP. Real-world case studies provide engaging examples of what to do and how to accomplish it.
11:00 - 12:00pm - 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 - Lunch
1:00 - 2:00pm - EU MDR
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. Technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more will be affected. New requirements are coming into play, including Eudamed and periodic safety update reports (PSURs). Learn 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 - 3:00pm – MEDDEV 2.7/1
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.
3:00pm – Drinks on us! Discussion and Networking
Enjoy two drinks on us in the Pittsburgh Technology Council's Atrium right after the event! Thought leader networking reception (includes appetizers, too), Q&A, and closing remarks - please join us! Two drink tickets per person will be offered.
Date: June 6, 2017
Time: 8 a.m. - 3 p.m.
Location: Pittsburgh Technology Council
2000 Technology Drive
Pittsburgh, PA 15219
$99 Members / $149 Non-members
For more information, please contact Jennifer Young
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Pre-Registration is always requested, when possible, so that we may best plan for your arrival. Walk-in registrants, when accepted, must pay onsite with a credit card or check to obtain entry to the event, no exceptions. Refunds requested less than 2 business days prior to the event will not be granted. Substitutions are welcome.
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