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MDR Clinical Evaluation Reports: Key Elements and Lessons Learned for Successful Compliance



February 25, 2021

Access On-Demand Webinar Here.

As the MDR mandatory implementation date approaches, several manufacturers continue to question their preparedness for compliance. To date, NAMSA has supported numerous clients through MDR transitions and as a result, has gained unique perspectives from these projects, including Notified Body feedback.

NAMSA invites you to join us for this webinar, which will include a panel discussion with our medical writing experts. Attendees will walk away with unique solutions and strategies for successful MDR planning to meet the May 25, 2021 conformity date.

Highlighted will be discussion on:

  • Insights and lessons learned from real-world client and Notified Body experiences
  • How to expertly apply requirements for Clinical Evaluation Reports (CERs)
  • Helpful considerations as the medical device industry approaches MDR deadlines

There will also be an opportunity to address the panel in a Q&A session during the last 15 minutes of the webinar. If you have a topic or question you would like to submit prior to the webinar, you can do so by contacting us at communications@namsa.com.

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com

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Adrian Keene, BSc (Hons)

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

With 26 years of experience in the medical device industry, Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products.

Prior to working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS. Before working with the notified body, he was Global Clinical Affairs and Regulatory Manager for Medical Devices, with responsibility for conformity assessment activities of high risk (class III) devices under the Medical Device Directive (MDD).

He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.

Severine Oudin-Fantin

Principal Medical Writer

Severine Oudin-Fantin has 15+ years experience as a Medical Writer with 10+ of those years focused in the medical device industry. She has been involved in the preparation of numerous Clinical Evaluation Reports for medical devices under MDD requirements, MEDDEV 2.7.1 Rev.4 and now MDR 2017/745. With a wide range of working knowledge in several therapeutic areas, Severine has been involved in the development of procedures and templates for clinical evaluation process and is involved in the training of the Medical Writing team at NAMSA. She received her PhD in 2004.

Federica Colonna

Principal Medical Writer

Federica provides strategy and execution as part of NAMSA’s North American Medical Writing Services team with a focus on clinical evaluations and meta-analyses, assisting clients globally and across multiple medical fields. Prior to joining NAMSA, she worked in industry, specializing in Clinical Evaluation Reports (CERs) and publications. Earlier on, she spent a decade in scholarly publishing, managing a bio-medical publication and working with different publishers and academic organizations. She leverages her experience in medical and regulatory writing to help clients navigate interactions with Notified Bodies and prepare submissions. She has a Master’s of Science in Health Communications from Ecole Normale Superieure (Paris Saclay, formerly Cachan) and a Master’s of Science in Biology and Society from Arizona State University.