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