Animal Tissue Use in Medical Devices – Webinar Recording/Transcript

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Animal Tissue Use in Medical Devices: Understand Regulation Changes and Implement Compliant Systems

Implementing compliant systems for medical devices with animal tissue requires multiple control layers, typically using standards in the ISO 22442 family — some of which are under revision. Add in the recent FDA-CDRH guidance, the EU-MDD and the EU-MDR and you have an incredibly complex, interlocking and changing defense system for animal tissue use. This webinar will cover all the new information you need to implement compliant systems that protect patient and user health.

Presentation Takeaways:

Industry expert Dan O’Leary, President of Ombu Enterprises, LLC, will explain:

  • Elements of the FDA guidance document and how they fit into the US regulatory system
  • Members of the ISO 22442 family and how they work together
    • ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management
    • ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection, and handling
    • ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    • ISO/TR 22442-4:2010 Medical devices utilizing animal tissues and their derivatives – Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
  • Upcoming changes to the ISO 22442 family
  • Approach to animal tissues in the EU-MDD and EU-MDR and the factors for implementation

Special Bonus: Receive a set of checklists to help implement the requirements for animal tissue use.

Using animal tissue in medical devices is complex and requires an integrated, cross-functional approach. This presentation is exactly what you need to ensure your systems are compliant and protect patients.

  • Design Engineering Managers
  • Design Engineers
  • Production Managers
  • Production Supervisors
  • Production Engineers
  • Quality Managers
  • Quality Engineers
  • Purchasing Managers
  • Purchasing Agents
  • Supplier Quality Engineers

Dan O’Leary is the president of Ombu Enterprises, LLC. He has more than 30 years’ experience in quality, operations and program management in regulated industries including medical devices and clinical laboratories. He has a Masters Degree in Mathematics; is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.