Sampling of survey feedback from the initial broadcast on September 12, 2019:
"Thank you! I have been in the medical device industry for 20 years, and this was possibly the best webinar I have ever attended. Your team obviously has a deep and detailed understanding of the challenges of moving CERs to EU MDR compliance."
"It was very clear that a huge amount of effort went into this webinar from the organizers and speakers. Well done, and I would fully recommend my colleagues keep following your company."
"I always enjoy and learn from the high quality R&Q webinars. Rather than just skimming the surface and giving high level explanations, they typically provide thoughtful and in-depth descriptions, explanations, and interpretations based on experience and expertise. This workshop was a very nice deep dive into a topic that is very relevant to many in the medical device industry now. Great speakers and contributors, as always."
"The webinar was excellent, as expected. The vast amount of knowledge of the presenters is impressive."
"It was as if you were vocalizing what I was thinking. Instances when clinical data may not be deemed appropriate for lower risk/class per Article 61 paragraph 10 is one of the songs I sing here, for example. It was nice to hear you asking about the same things I was wondering!"
"I have taken a few classes/webinars on this topic from other companies, but this time the topics were well explained. The discussion section also provide interesting approaches to the topics."
"I am going to share the replay of the webinar with several team members. The topic is relevant to us and the language was simple and clear, and I understood over 90% of the conversations. Many of the Q&A sessions were questions we have here. Good Job!"
"It was great. I would not change a thing! Very comprehensive and informative."
"There were a lot of excellent questions and I heard answers or at least gained input about many things having to do with MDR and my area of interest (PMCF). It was fantastic to hear about how other companies are handling this and what notified bodies expect. Great job."
"Very helpful to have brief presentations intertwined with the panel of experts."
"I really enjoyed the webinar & learned a lot from it! Great job!"
"These are great! Keep up the good work guys!"
"It was a great workshop, I look forward to attending future workshops."
"This was the best workshop I have attended in a long time."
"Very useful and well presented information."
Case studies and tips for EU MDR compliant CERs from two panels of leading experts.
R&Q's CER Virtual Workshop contains the insight you've been waiting for!
Agenda
Noon – 12:30pm
What’s R&Q seeing? A CER state of the union.
R&Q has been submitting EU MDR compliant CERs for several months now. This introductory workshop session will explain what we’ve seen from the industry at a high level, revisit some of the most pertinent regulations, and share how notified bodies have reacted thus far. Are products coming off the market? Have notified bodies been harder on manufacturers than expected? The intent of this session is to prepare attendees to get the most out of the panel discussions to follow.
Presenter:
– Jon Gimbel Ph.D., Executive Director and CER Business Unit Lead – R&Q
12:30 – 1:30pm
Q&A Panel: CERs
Panelists:
– Ibim Tariah Ph.D., Vice President of EU MDR and IVDR Consulting Services – R&Q
– Gregor Dzialas, Director of Regulatory Affairs – Fresenius Medical Care, North America
– Jon Gimbel Ph.D., Executive Director and CER Business Unit Lead – R&Q
– Ron Sills, Senior Principal Specialist – R&Q (former TUV)
1:30 – 2:00pm
Integrating CERs and Post-Market Surveillance
CEP, CER, PMS Plan, PMS Report, PSUR and SSCP: With a variety of new requirements detailed in EU MDR, integrating the clinical, regulatory, risk management, and post-market documentation is a difficult and confusing task for both small and large organizations. There are overlapping requirements and consistent information needs to be included in a variety of plans and reports. R&Q will briefly explain how the data inputs and outputs for these documents are interrelated and provide guidance on how to share information throughout the organization to streamline processes and ensure consistency.
Presenter:
– Brian Hockett, Project Engineer – R&Q
2:00 – 3:00pm
Q&A Panel: Integrating CERs and Post-Market Surveillance
Panelists:
– Ibim Tariah Ph.D., Vice President of EU MDR and IVDR Consulting Services – R&Q
– Ken Barry, Manager, Post-Market Surveillance – Stryker
– Jon Gimbel Ph.D., Executive Director and CER Business Unit Lead – R&Q
– Brian Hockett, Project Engineer – R&Q
Presenter and panelist biographies
Ibim Tariah Ph.D., Vice President of EU MDR and IVDR Consulting Services
Regulatory & Quality Solutions (R&Q)
Dr. Ibim Tariah earned his PhD in Materials Science the University of Manchester, U.K. Dr. Tariah has over 30 years experience in the medical device industry, including 21 years at BSI. In Dr. Tariah's role of VP of EU MDR/IVDR Consulting Services at R&Q, he provides leadership, strategic advisement and implementation expertise to R&Q's consulting team and medical device clients. Prior to R&Q in his role of Technical Director of Medical Devices for BSI Americas, Dr. Tariah was part of the BSI Americas leadership team responsible for transitioning from MDD to MDR certification. Dr. Tariah recognized the significant challenges in implementation of the EU MDR. He created and led customized MDD and MDR workshops for clients and industry, and spoke on behalf of the notified body at global conferences and events. At BSI, Dr. Tariah also provided expertise in innovative vascular, orthopedic, dental, and other long term implantable devices for clients needing technical documentation assessment and reviews in compliance with the MDD and MDR. Dr. Tariah acted as a client liaison to Regulatory Authorities including MHRA (UK), European Medicines Agency (EMA),and Medical Products Agency (Sweden). Prior to his role at BSI, Dr. Tariah led global organizations through successful product development. His vast experience includes Regulatory knowledge of combination devices incorporating biologics, drugs and drug-biologics along with Quality Assessment of Medical Devices.
Gregor Dzialas – Director of Regulatory Affairs
Fresenius Medical Care, North America
Gregor has worked over 25 years in regulatory affairs for the medical device sector, both for large device companies and EU regulators. He started his career as medical device lead auditor, certification officer and manager of FDA’s third-party programs for the Notified Bodies TÜV SÜD and TUV Rheinland. In 2009 he transitioned to the device industry, applying his in depth knowledge of EU and US regulations to improve QMS processes and compliance at Boston Scientific.
In his current position as Director of Regulatory Affairs at Fresenius Medical Care / NxStage, he has responsibility for global market authorizations, including developing regulatory and clinical strategies for dialysis systems and drug/device combination products, and he leads the effort for the implementation of the EU MDR. He holds degrees in biology from University of Cologne and biomedical engineering from the College of Engineering Giessen-Friedberg.
Jon Gimbel, Ph.D. – Executive Director and CER Business Unit Lead
Regulatory & Quality Solutions (R&Q)
Jon has worked in the biomedical and medical device area for nearly 20 years, acting as a key member in a medical device startup, a consultant to a wide variety of medical device companies, and as a researcher on both academic and industrial projects. Having a thorough understanding of the ever-changing global regulations, Jon leads R&Q’s CER business unit and has been successful implementing regulations at multinational medical device companies: delivering business-balanced solutions for their business-balanced demands. Jon oversees clinical evaluations completed by R&Q and helps ensure compliance to MEDDEV 2.7/1 Rev 4. Jon also works with companies to develop strategies and plans to meet the new EU MDR requirements pertaining to clinical evaluations and post-market activities. Jon holds a Ph.D. in Mechanical Engineering and BioEngineering, and a Master’s degree in Mechanical Engineering, from the University of Pennsylvania. Jon received his Bachelor’s degree in the same subject from Penn State University.
Ken Barry – Manager, Post-Market Surveillance
Stryker
Ken has worked a Stryker for 12 years supporting Divisional Quality in both pre-market and post-market activities. He has served as the Divisional Process Owner for the Risk Management Process over the last two years, ensuring compliance to ISO 14971. Most recently, Ken has managed the post market monitoring team, where his teams have led activities related to safety signal detection and product trending. Additionally, Ken led the divisional process updates to the cumulative post market surveillance process for compliance to EU MDR.
Brian Hockett – Project Engineer
Regulatory & Quality Solutions (R&Q)
Brian Hockett is a Project Engineer at Regulatory & Quality Solutions (R&Q). Brian is a skilled medical device professional with experience in design, development, risk management, regulatory submissions, and quality management systems. He has worked in both startups and large medical device organizations, and has been a key member of corporate integration and remediation teams. Brian has helped lead quality system updates and implementation for ISO certification, FDA and notified body audit preparation and defense, as well as directed design and development efforts, and design quality assurance projects.
Brian currently works with companies to develop strategies and plans to meet the new EU MDR requirements for their technical documentation, post-market surveillance, and QMS. Brian has a Bachelor of Science Degree in Biomedical Engineering from Case Western Reserve University.
Ron Sills – Senior Principal Specialist
Regulatory & Quality Solutions (R&Q) (former TUV Rheinland)
Ron recently joined R&Q after collaborating with us on panel discussions, roadshow events, and webinars while a Lead Auditor of TUV Rheinland. He has authorizations for ISO 13485, ISO 9001, MDD, IVDD, CMDCAS and MDSAP. He's also a subject matter expert on sterilization technologies and validation, hygiene and clean room certification, and biocompatibility. In the past Ron has developed clinical evaluation report services, as well as providing expert research services for clients in the medical devices, pharmaceutical, and life sciences industries. He has also worked for medical device companies, including ACMI and US Surgical (Medtronic) as a QA Manager and QMS Management Representative.
Theresa Miles – Account Director and Director of Sales Training
Regulatory & Quality Solutions (R&Q)
Moderator
Theresa has 25+ years’ experience highlighting an eclectic background as a leader in quality system compliance, clinical laboratory compliance, and clinical research activities. She has extensive skills and experience with CAPA development / execution, quality management systems, auditing and training. Theresa earned a Bachelor of Science degree in Biology from Saint Francis University. As Account Director and Director of Sales Training, Theresa’s role for R&Q today includes working closely with new clients to solve their regulatory and quality challenges through business-balanced solutions, routinely going above and beyond to delight in the process.
