The medical device industry has a long and successful history in the use of tissues of animal origin in the design and manufacture of medical devices. However, with the first appearance in the mid 1990s of a variant form of Creutzfeldt-Jakob Disease (vCJD), a fatal brain disease of humans, as a result of the bovine spongiform encephalopathy (BSE or “mad-cow” disease) epidemic in the UK, regulatory requirements were enacted in the European Community aimed at minimizing the inherent risks associated with the safe use of such devices. This audio conference presentation discusses the risks inherent in devices using tissues of animal origin, and reviews the various European regulatory requirements and guidance documents applicable to such medical devices.

This audio conference covers:

• The significance of Transmissible Spongiform Encephalopathies and other transmissible agents, and the inherent risks they pose with medical devices manufactured utilizing tissues of animal origin
• Regulatory requirements for medical devices manufactured utilizing tissues of animal origin (Directives 93/42/EEC, 2007/47/EC, 2003/32/EC and Decision 2007/453/EC)
• Review of applicable guidance documents/harmonized standards (MEDDEV 2.11/1, EMEA/410/01 Rev. 3, EN ISO 22442-1, -2, -3:2007)

About the speaker:

Steve Coppockis an MHS Auditor with TÜV SÜD America, Inc. Since April 2010, his work has focused primarily on non-active medical devices with expertise in sterilization, heart valves and animal origin medical devices. Steve has over 30 years of quality and regulatory management experience in the medical device industry, primarily with tissue heart valves as well as other cardiovascular/vascular and orthopedic devices, holding positions at Hancock Laboratories, Xenomedica AG, Baxter-Edwards CVS Division, Bravo Cardiovascular Inc., CryoLife Inc., VenPro Corporation and Arbor Surgical Technologies Inc. He holds a BS degree in medical microbiology and is one of the pioneers in liquid chemical sterilization of tissue heart valves.

Who should attend?

• Managers/Directors of Regulatory Affairs
• Managers/Directors of Quality and Quality Systems
• Managers/Directors of Manufacturing, including Tissue Procurement Managers
• Managers/Directors of Microbiology