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MDR Summit Tokyo



Date(s) - June 11, 2024
10:00 AM - 04:00 PM JST


Nihonbashi Life Science Building
2 Chome-3-11 Nihonbashihoncho, Chuo,
Tokyo, 103-0023


MDR Summit

Date: 11 June 2024
Location: Nihonbashi Life Science Building
Price: $200 USD

NAMSA is delighted to be back in Tokyo for another MDR summit, led by one of our foremost experts on MDR: Adrian Keene, Associate Vice President of Global Biological Safety & Validation and EMEA Consulting Services (for more information, please review the Speaker information below). Joining him will be Sara Finocchietti, Senior Strategy Consultant, Clinical, bringing a wealth of experience of EU Post Market Clinical Follow-Up (PMCF) study implementation.

This half-day summit provides practical solutions for navigating the European Union Medical Device Regulation (EU MDR), including a dedicated session on developing and implementing PMCF strategies, with case studies. Designed for professionals in the medical device industry, this course will equip you with the knowledge and skills you need to successfully implement the EU MDR requirements in your organization.

Please review the Agenda below for further information.

Attendees will have the opportunity to ask questions during the interactive Q&A session, as well as extensive time available in the afternoon to discuss with our experts.


MDR Summit

所在地 日本橋ライフサイエンスビルディング


この半日のサミットでは、欧州連合医療機器規制(EU MDR)をナビゲートするための実践的なソリューションを提供します。このコースは、医療機器業界のプロフェッショナルを対象としており、EU MDR要求事項の導入を成功させるために必要な知識とスキルを身につけることができます。







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MDR Summit Tokyo

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10:00 – 10:30

Welcome/Coffee / ウェルカム/コーヒー

10:30 – 12:00

Part 1 / パート1
  • Update and implications of the extension of the MDR transition period MDR
  • Key considerations for transitioning your EU device portfolio to the MDR EU
  • Experience from deficiencies and feedback observed from notified bodies

12:00 – 13:00

Lunch / 昼食

13:00 – 15:00

Part 2 / パート2
  • Post market surveillance (PMS) and post market clinical follow up (PMCF) requirements
  • Developing your PMCF strategy to meet both your business and EU regulatory requirements
  • Practical considerations for implementing your PMCF strategy PMCF
  • Case studies in PMCF implementation PMCF
  • (including Q&A)


15:00 – 16:00


Adrian Keene and Sara Finocchietti will be available to discuss.

Please note that you can leave before the end of the networking session if you need to.


Adrian Keene, BSc (Hons)

Associate Vice President of Global Biological Safety & Validation and EMEA Consulting Services

Adrian has more than 30 years of experience in product development and registration within the medical device industry, with manufacturer, regulatory agency, and consultancy perspectives. Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced and pragmatic interpretation of the needs and expectations of both regulators and manufacturers. Before working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS and spent 10 years in the Notified Body sector, where he was responsible for conformity assessment activities of high-risk (class III) devices under the Medical Device Directive (MDD).

He is a toxicologist by training and worked for several years in the Research and Development (R&D) sector of the medical device industry, providing toxicological and risk management strategies to expedite product launches for multiple global registrations.

Sara Finocchietti

Senior Strategy Consultant, Clinical

Sara Finocchietti has over 15 years of experience in the medical device industry with a wide range of therapeutic areas. Her core focus has been on orthopedics, neurovascular and neuroscience. Her career started in academia developing innovative medical devices and providing clinical and regulatory strategy. Her previous experiences include working as a Clinical Affairs Manager at a French manufacturer with a full orthopedic portfolio, defining the strategy to transition to the EU’s Medical Device Regulation (MDR).

Sara holds an MSc in Biomedical Engineering from the University of Genoa (Italy) and a PhD in Clinical Science from Aalborg University (Denmark).