Coatings in Medical Devices – ISO 17327
Instructor:
Gary Fischman
Product ID: 706059
- Duration: 60 Min
Why Should You Attend:
If you are thinking of using a coating in a medical device, you need to understand something about them.
Coatings at some level have been used in the medical device industry for decades and their use is quite broad. Understanding what a coating is, what its issue might be and what issues might be of concern to regulators is an important part of the decision process of what to use and how to test a coating.
ISO 17327 – Implants for Surgery: Non-active surgical implants – Implant coating – Part 1: General Requirements is the broad 1st part of several likely documents to be created for the purpose assessing, understanding and regulating the use of coatings in medical devices.
In this webinar, you will be given a short introduction to coatings in general, an introduction to the concepts in ISO 17327 a feeling for what issues might come up with different types of materials coating systems.
Areas Covered in the Webinar:
- What is a coating system?
- Types of coatings
- Coating processes
- Standards
- Communities of interest and who might standardize what
- An introduction to ISO 17327
- Some controversies regarding ISO 17327
- Path forward
Who Will Benefit:
- Chief Technology Officers
- Mechanical or biomedical engineers
- Chief Regulatory officers
- Regulatory staffs
Gary Fischman
Principal, Future Strategy Solutions LLC
Dr. Gary Fischman is a materials scientist/engineer with a PhD in Ceramic Engineering. He is the principal officer of Future Strategy Solutions (futurestrategysolutions.com) and the CTO of Covalent Coatings Technologies (covalent-coating-technologies.com). He was a material specialist at the US FDA in the 1990s and beyond that has served as Director of Biomaterials and Technologies in the College of Dentistry at UIC where he had joint appointments in Restorative Dentistry, Orthopaedic Surgery and Bioengineering.
He is a fellow of the American Ceramic Society (in which he has served as a Director) as well as the National Institute of Ceramic Engineers (which he has served as President). He is currently the chair of ASTM F04.13 (Ceramics for Surgical and Medical Implants and Materials) and will be stepping into the convenership of ISO TC 150 WG12 (Implants for Surgery: Coatings) in 2019.
Beyond that, Dr. Fischman was the Director of 3 boards at the National Academies (National Materials Advisory Board, the Board on Manufacturing and Engineering Design and the Board on Infrastructure and the Constructed Environment) where he managed several programs (which included the Biomedical Engineering and Materials Applications (BEMA) Roundtable). He was also a tenured faculty member at the New York State College of Ceramics at Alfred University.
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