EU MDR Implementation Strategies Virtual Workshop

We are confirming the speakers for the EU MDR Implementation Strategies Workshop now and will announce them soon!

Expect to see Subject Matter Experts from medical device companies and from organizations who advise the industry.



Speakers

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Momchil Blagoev
Director Corporate Regulatory Affairs, Edwards
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Mark Cusworth
VP, Research & Development, PRISYM ID
Mark Cusworth has more than 15 years of experience heading up a team providing off the shelf and tailored solutions to life science companies. During this time, he has seen many changes to the industry including significant tightening of regulations such as EU MDR and challenges of globalization. His primary objectives are to target the ongoing investment in research, development and quality effectively and to lead the company in-house research and development.
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Kristin Dudek
Sr. Staff Regulatory Affairs Specialist, Stryker
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Keith Morel, PhD
Vice President, Regulatory Compliance, Qserve
Keith is responsible for technical consulting, as well as business development and sales. Keith has experience and competence with a large range of devices (Wound care, Vascular, (active) implants, combination devices, IVUS)

The key expertise areas of Keith

Medical Device Regulatory Affairs (RA) and Quality System expert (Europe, Canada, USA) with 17 years in medical device industry
Leader capable of building successful teams by critically assessing performance capabilities and developing talent
Broad medical device industry experience which includes RA, R&D and Quality Engineering functions
Risk Management (EN ISO 14971:2012) and Clinical Evaluation (MEDDEV 2.7.1) Thought Leader
Professional Regulatory and Quality System Auditor

Before Qserve

Keith was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer).Keith was also a Senior Project Manager for DEKRA Certification for 9 years. During his time at DEKRA he was a quality system and regulatory lead auditor, as well as a design dossier reviewer. He performed more than 100 audits and 200 Design Dossier/Technical File reviews. Before DEKRA, Keith worked in R&D in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products.

He holds both a First-Class degree and a Ph.D. in Physics from Imperial College of Science, Technology and Medicine, in London.
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Nic Pugliano
Regulatory Affairs, W. L. Gore & Associates, Inc. - Medical Products Division
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Erik Vollebregt
Axon Lawyers
Erik specialises in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as expert witness in foreign litigation.

Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.
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Michael Gyr
Sr Manager Regulatory Affairs EMEA, Varian Medical Systems
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Beatrice Wan
Senior Staff Regulatory Affairs Specialist, Stryker
US and EU RAC certified regulatory professional with over 8 years of cross-functional experience in medical device new product development including R&D, operations and quality. Regulatory experience in US, Europe, and emerging markets such as 510(k) clearance, FDA class III supplement, EU Technical Files and Design Dossiers, and successful registrations in China, Japan, Southeast Asia, and Latin America. Previously served as a regulatory platform leader, leading a team of 3 with accountability for global regulatory responsibility for both pre-market and post-market activities.
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Paul van Geffen, PhD
QA/RA Expert Senior Consultant, Qserve
The key expertise areas of Paul

Medical Device Directive (93/42/EEC) and Medical Device Regulation (2017/745)
QMS development (ISO 13485, FDA QSR)
TF set-up/ review (CE mark and, to lesser extent, 510k)
Design controls and risk management (ISO 14971)
Biological evaluations (ISO 10993 series)
Clinical evaluations (MEDDEV 2.7/1)
European collaborative research projects (FP7)
Program-/ project management

Besides that, I am a certified trainer, (lead) auditor, and bio-compatibility expert

Paul has degrees in Human Technology (BSc, 2001), Human Movement Science (MSc, 2004) and Biomedical Engineering (PhD, 2009). His dissertation was about the design, development and clinical investigation of a novel seating system enhancing functional movement and preventing physical discomfort in impaired static wheelchair sitting.
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James Wabby
Executive Director, Regulatory Affairs (Devices and Combination Products), Allergen
• Serves as the person responsible for regulatory compliance (Medical Device Regulation – MDR and IVDR), US Agent and back-up management representative for device and combination products
• Develops effective regulatory strategies and execution of regulatory activities for product lifecycle management including product development, commercialization, and post-marketing
• Leads the Global Regulatory Affairs team for submissions, periodic reports, incident reports and activities necessary for FDA and international product license/registration for regulatory compliance
• Leads and supports regulatory objectives for development and marketed device/combination products including coordination management of global submissions and CE technical files/design dossiers
• Directs and supports submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), post-approval reports, annual reports, change notices, supplements, export certificates, establishment registrations, tissue banks and device listings
• Directs the ISO 13485:2003 transition to ISO 13485:2016 and MDSAP program implementation
• Directs the 21 CFR Part 4 – Combination Products Post-Market Safety Reporting program implementation
• Directs the (Medical Device Regulation – MDR and IVDR) program implementation
• Supports the development of the device regulatory strategy and provides input into the preparation and maintenance of (CMC) device sections of regulatory submissions, responses to regulatory authorities, notified bodies for global registrations and lifecycle management of device aspects for combination products
• Supports regulatory intelligence and policy activities
• Represents the company at Regulatory Authority/Notified Body project meetings
• Regulatory Lead for Field Corrective Action, IDE recovery and Recall Management Programs
• Directs/Supports the strategy for global regulatory planning for due diligence projects, integrations and divestitures
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Anjali Atal-Gupta
Senior Manager, Regulatory Affairs, Stryker
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Gert Bos
Executive Director & Partner Leading MDR-Expert, Qserve
Gert has 26 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting.

He is a president-elect and member of the Board of Directors of RAPS, founding member of the Board of Directors of RAPS Europe and a founding board member of the Dutch RAPS Chapter.

Gert provides strategic consulting on complex regulatory matters, on interactions with Notified Bodies and EU pharma agencies, on suspensions and cancellations of certificates, field safety corrective actions and more. He is supporting due diligence processes from RA/QA perspective. And finally, he provides insightful dedicated in-house training on regulatory matters, including EU-MDR and EU-IVDR.

Before joining Qserve, he served 7 years as Head of Regulatory and Clinical Affairs of BSI (NB0086) and Head of Notified Body at BSI-Germany (NB0535), and a similar time as head of the certification team at KEMA (now Dekra, NB0344).

He has served as President of the Notified Body Association TEAM-NB, and as Chair and Vice-Chair of the Medical Notified Body forum NB-Med in Brussels for over a decade. In these roles, he represented Notified Bodies in many EU Commission meetings and workgroups and represented Notified Bodies in the process of drafting and finalizing the EU-MDR.
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Royth Von Hahn,
Senior Vice President Medical & Health Services, TÜV SÜD
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