BSI Passport to Europe Series
Thursday March 18, 2010
1:00pm - 2:00pm EST
Are you aware of the impact Clinical Evaluation has on placing your Medical Device in the European Union? This exciting market is made up of 27 countries and if you want to sell your product in Europe, obtaining a CE Mark is mandatory. This requires a Device manufacturer to comply with the European Medical Device Directive (MDD) regulations in which Clinical Evaluation is a key requirement.
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the medical device. Come join BSI to gain an understanding of Clinical Evaluation process which covers the totality of information used to demonstrate compliance and can include: Clinical Trial, Literature Review and Product Performance History.
Learning Objectives
- Understand the European Regulatory Framework
- Definition of Clinical Data
- Learn the Clinical Evaluation Process
- How the scope of data required is proportional to the Risk of the Device
- Obtain a listing of useful resources
Who should attend?
- Emerging, New or Small Medical Device Companies
- New Regulatory Affairs and Quality Professionals
- Suppliers
- Organizations New to the International Medical Device Market
- Marketing Professionals
- Medical Device Venture Capitalists
- Persons who are involved in placing Devices on the Global Markets
- Medical Device Design Engineers
Audience
Presenter: Ibim Tariah
Dr. Ibim Tariah is the Technical Director for the Vascular Therapies Group within BSI Healthcare. He earned his PhD in Materials Science with emphasis on polymer science and technology from the University of Manchester, U.K. Dr. Tariah has over 20 years experience in the medical device industry in which he led global organizations in successful product development, project management and provided technical expertise in support of commercial efforts. In the last 12 years, since coming to BSI, Dr. Tariah has been providing expertise in vascular, orthopaedic and dental for clients needing technical documentation assessment and reviews in compliance with the Medical Device Directive (MDD). His vast experience includes Regulatory knowledge of combination devices incorporating biologics, drugs and drug-biologics along with Quality Assessment of Medical Devices. He also acts as a liaison with Regulatory Authorities including MHRA, European Medicines Evaluation Agency (EMEA), Medical Products Agency (Sweden) FDA, Health Canada and Therapeutic Goods Administration (TGA).
