Go to Client Portal
NAMSA

Clinical Data Requirements Under MDR: A Panel Discussion

About

Date/Time

Date(s) - April 16, 2024
10:00 AM - 11:00 AM CT

Register Now

 

NAMSA invites you to join us for an interactive panel discussion on clinical data requirements and challenges under MDR, led by our in-house regulatory experts. Even with the extended MDR transition period for legacy devices, it’s crucial to have a strong clinical data plan for all devices. We’ll begin by addressing common clinical data challenges manufacturers face under MDR, drawing from our experience with clients and notified bodies. Then, we’ll dive into an interactive panel discussion.

Attendees will gain insights into:

  • Clinical Evaluation Report (CER) requirements
  • Defining adequate clinical evidence
  • Evaluating clinical benefits
  • Strategies for Post-Market Follow-Up (PMCF)
  • Expectations of Notified Bodies regarding clinical data

 

The session will include time for Q&A

 

*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

NAMSA uses a third-party provider, GoToWebcast, to host NAMSA webinars. For information related to GoToWebcast’s privacy policy and utilization of information, please contact GoToWebcast directly.

Speaker

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.

Kevin Butcher

Principal Regulatory Consultant

Kevin is a 20-year veteran of the medical device industry, both with Notified Bodies and in industry with primary industry experience in active devices, principally in Radiotherapy, X-Ray, Kidney Dialysis, Monitoring and Administration.

Kevin’s career experience includes positions at Gambro Ltd and Elekta Ltd before joining AMTAC/Intertek in 2003. He oversaw and conducted Product Conformity Assessment audits and Technical Documentation reviews against European Directive 93/42/EEC requirements. Following, Mr. Butcher moved into management positions within Notified Bodies (AMTAC/Intertek & SGS United Kingdom Ltd) with roles in operational and technical areas, eventually becoming Certification Manager for SGS United Kingdom and SGS Belgium Notified Bodies.

Kevin joined NAMSA in January 2021, the focus of his work is on complex regulatory submissions for active devices, including the development of regulatory and clinical strategies and MDR transition strategies; technical documentation compilation; MDR QMS transition consultations; the new United Kingdom UKCA regulatory process; and regulatory due diligence.

Kevin has a Higher National Diploma in Electrical and Electronic Engineering. He was previously an IRCA Registered Principal Auditor and Vice President of Team-NB.

Caroline Guidicelli

Caroline Guidicelli

Principal Medical Writer

Caroline began her career in the medical device field as a Manufacturing Engineer for a multinational company selling implantable orthopedic devices. Following, she worked as a self-employed Medical Writer authoring Clinical Evaluation Reports (CERs). She joined NAMSA in 2019, where the focus of her role is to write and review CERs for compliance with the European Medical Device Directive 93/42/EEC (MDD) and/or with the European Medical Device Regulation 2017/745 (MDR). She has also been involved in developing Clinical Study Reports (CSRs) following ISO 14155 and Annual Progress Reports (APRs) for the FDA.

She has worked with numerous manufacturers on all classes of medical devices and a variety of therapeutic areas, including surgical instruments, wound care, orthopedics, dental bone substitutes and neurovascular aneurysm repair. She also participates in the development of templates, work instructions and Standard Operating Procedures (SOPs) for clinical evaluation.

Caroline holds a Master of Engineering in mechanical engineering and polymer processing, as well as a Master of Science in innovative materials.

Beatriz Rodriguez

Team Leader Medical Writing & Manager Consulting of Global Talent Center

With a background in Neuroscience research, Beatriz started working in industry in 2019, within medical affairs in a pharmaceutical company. In 2021 she joined a medical device consulting company, where she worked as Regulatory Affairs Manager, supporting the development of a team trained in the European Medical Device Regulation 2017/745 (MDR). Beatriz joined NAMSA in 2023, where she leads a group of medical writers mainly focused on clinical evaluations and is a teacher at several local University Master´s programs.

Beatriz has helped clients on MDR adoption through strategic consulting and development of clinical evaluations, MDD to MDR gap assessments, literature reviews, SSCPs, post-market documentation and other technical documentation. She has worked closely with the clinical department to provide solutions for meeting the requirements for obtaining a CE-mark for a diversity of manufacturers, from start-ups to multinational companies, and with a variety of products, from well-established technologies to innovative devices at various stages of development.