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Description
Join industry leaders as they discuss the intricacies of Post-Market Clinical Follow-up (PMCF), covering regulatory aspects, surveys, and clinical studies. NASMA experts will share best practices that help manufacturers meet the requirements of the MDR and Notified Body expectations.
Engage with our experts through polls and live questions. You can share your experiences with PMCF and Notified Bodies and send your questions in advance to communications@namsa.com to ensure they are addressed during the webinar.
Key Learning Objectives:
- Understand the context of PMCF within the EU MDR
- To understand the differences between surveys and studies
- To identify the appropriate PMCF strategy based on the type of device and how long it has been on the market.
- Best practices for developing surveys
- Best practices for developing PMCF studies
Speakers
Senior Strategy Consultant, Clinical
Sara Finocchietti has 15 years of experience in the medical device industry, in a wide range of therapeutic areas, with a specific focus on orthopedics, neurovascular and neuroscience. Her career started in public research developing innovative medical devices as well as providing clinical and regulatory strategy for market access in Europe. 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). She has been an Assistant Professor in Biomedical Engineering in Denmark and Guest Professor in Clinical Research in Italy.
Senior Business Consultant, SUAZIO (Now Part of NAMSA)
Jasper has been in the industry for 20 years with 15 years focused on medical devices specifically in these therapeutic areas: Orthopedics, Cardiovascular and Neurology. Jasper was previously leading market insights and new business development analytics in Johnson&Johnson, Medtronic and two small startups. In his market insight roles, Jasper explored numerous market opportunity assessments, gap analysis, concept testing’s, pricing studies and M&A assessments. In the recent years also conducting real world evidence and PMCF studies. He holds a master’s degree in Economic Psychology and a bachelor’s degree in Physiotherapy.
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. His current responsibilities at NAMSA are leading both the global biological safety and validation teams and the EMEA regulatory teams.
Principal Regulatory Consultant
Paul Risborough, who joined NAMSA in June 2021, has over 25 years of experience in the medical device industry, working with many active medical device technologies. Paul began his medical device career as an Electronics Technician supporting the design and manufacture of syringe pumps. He stayed in the infusion device industry for several years, developing the Alaris range of syringe pumps and large-volume pumps as an Electronics Design Engineer, Production Engineer, and Electronics Engineering Manager. Mr. Risborough’s regulatory career began when he joined BSI as an Active Device Product Specialist in 2011. In 2013, Paul was appointed as part of the BSI Active Implantable Medical Device (AIMD) Team and, in 2015, was promoted to the Global Head of Active Implantable Medical Devices. He has developed several MDR-compliant PMS plans, PMCF plans, PMCF surveys, PMCF reports, and PSURs for various active and non-active devices.
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