BSI Passport to Europe Series
Thursday April 8, 2010
1:00pm - 2:00pm EST
Risk Management continues to receive increased attention and can be challenging for many medical device manufactures. It is an important part of the integrated regulatory process to achieve CE marking, which is a legal requirement to sell a device into the 27 countries of the European Union. Another vital part is an effective Quality Management System (QMS). The majority of manufacturers base their QMS on the ISO 13485:2003 standard which in turn requires the organization to establish documented requirements for risk management.
ISO 14971 is a state-of-the-art, international standard that is recognized as the best process to ensure that all aspects of risk management are considered throughout the medical device lifecycle, from concept to disposal. This Webinar introduces the basic steps needed to get started, the role of top management and how medical device manufacturers can minimize risks to help ensure their product benefits clearly outweigh risks.
Learning Objectives
- Overview of Risk Management in the medical device industry
- Basics of the Risk Management and ISO 14971 Standard
- Understand the relationship between ISO 14971, ISO 13485 and CE marking
- Requirement of Top Management in the process
- The role of a Notified Body
- Learn the key steps needed to meet the European Regulatory Requirements
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: Jonathan Degg
Co-presenter: Tammy Battisti
Jonathan Degg is Senior Client Specialist with BSI Healthcare and has over 19 years of experience in a comprehensive range of product certification assessments and quality management systems. He is certified as a lead assessor specializing in medical device regulations encompassing ISO 14971 Risk Management, CE marking, ISO 13485, IEC 60601 Medical Electrical Equipment and Japan PAL. Mr. Degg obtained his BSc in Applied Sciences from The Polytechnic, Wolverhampton in the UK.
Tammy Battisti is currently a BSI Senior Client Specialist with over 20 years of experience in a broad range of quality management systems, specializing in Medical Devices. She is a fully qualified auditor for FDA Accredited Persons Inspections Program along with assessments to the MDD, Canada CMDCAS, Japan PAL, ISO 13485, ISO 9000 and ISO 14000 standards. In addition, she conducts QMS and EMS training courses and webinars. Ms. Battisti holds dual B.S. degrees in Chemical Engineering and Physics.
