WHY I SHOULD JOIN THE WEBINAR:
A medical device containing animal origin material (or animal origin material is used as a manufacturing aid during production of the device) is preferred to be free of bacteria, moulds, yeasts, viruses, parasites, unclassified pathogens, Transmissible Spongiform Encephalopathy / Bovine Spongiform Encephalopathy (TSE/BSE), pyrogens, immunogens, and toxins. Advanced developments in the materials science field has provided non-biological materials for medical device industry. But there are still many medical device applications, heart valves, vascular devices, collagen, gelatin, etc., that uses biological materials for their superior performance, pliability, non-toxic, and mimic natural material. Therefore, there are risks associated in using biological materials in medical device.
Since it is highly unlikely to get a biological material free of all the above-mentioned microorganisms, it is necessary to mitigate the risks associated with it. FDA and international regulations require testing to ensure that the microbial risks are eliminated and in addition, the risks of TSE / BSE are mitigated to receive regulatory approval for devices.
The risks are device specific and must be evaluated in the following areas:
- Procuring materials
- Controls on the supplier
- Production
- Regulatory submissions
- Postproduction
- Device specific
ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management and ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling are important standards for manufacturer to demonstrate that the animal material used is free of bacteria, moulds, yeasts, viruses, parasites, unclassified pathogens, Transmissible Spongiform Encephalopathy / Bovine Spongiform Encephalopathy (TSE/BSE), pyrogens, immunogens, and toxins. The new revisions of these standards were released in July 2020; therefore the compliance shall be demonstrated by device manufacturer by June of 2023.
This webinar aims to provide comprehensive overview of the changes in ISO 22442-1:2015, part 1 and 2, technical considerations, and strategies for establishing compliance to ISO 22442-1:2020 and ISO 22442-2:2020. Participants will gain valuable insights from Subject Matter Expert from BridgeMed Solutions on how correctly approach Risk management and Controls on sourcing, collection and handling that are up to current industry standards and expectations by regulatory entities.
TOPICS:
Regulatory overview impacting Materials of Animal Origin:
- ISO 22442-1:2020
- ISO 22442-2:2020
WHO SHOULD PARTICIPATE:
- Procurement Manager
- R&D Managers
- QA Managers
- Regulatory Managers
- Production Managers
- Validation Managers
EVENT KEY NOTE SPEAKER:
Dr. Tara Kupumbati
Dr. Kupumbati holds M.Sc., and Ph.D. degrees in Infectious diseases and Microbiology/Virology. She is the Founder and CEO of BridgeMed Solutions, Inc., and has ~20 years of experience in Animal Origin Material standards. Has served as “Tissue safety Committee member” in AAMI to bring ISO 22442 series to USA. In addition, successfully helped many startups and global medical device companies to bring their product to compliance and obtain regulatory approvals. Currently working with many companies to fulfill their regulatory requirements.
** Israel Time Zone
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