*** In response to the COVID-19 pandemic, APTS Training has transitioned to a remote workforce. The decision aligns with our goal to lower the number of interactions on campus, slow the rate of transmission, and protect our community.
While all classes scheduled in March and April have been canceled, we are currently accepting registrations for courses scheduled after May 01, 2020. We will monitor the situation and may have additional cancelations.
Staff will be monitoring emails and voicemails. Our clients and instructors are very important to us, so please feel free to contact us. ***
C & T of Functional Coatings for Medical Devices - 1 Day Course
To be scheduled
Time: 9:00 AM - 1:00 PM
Location: Akron Polymer Training Center, Akron, OH 44325-5404, U.S.A.
Cost: $700.00 USD
Instructor: Mr. David Russell
Intended for newcomers to the medical device industry, this course provides an introduction to FDA and EU regulations as related to medical devices including definition of key terminology, overview of GMP, device classification, listing and approval processes and how to navigate the FDA website to access key resources provided. A broad range of materials are discussed. This includes conventional elastomers such as silicones, natural and synthetic polyisoprene, and polyisobutlyene; thermoplastic elastomers such as TPEs, TPVs, POEs, Copolyamides and TPUs. Engineering plastics such as polyesters, nylons, acetals, polycarbonates, conventional polyolefins and cyclic polyolefins are discussed. Applications identified include orthopedic devices, ophthamolics, viscoelastic gels, catheters, tubing, stoppers, drapes, syringes, transdermal drug, medical machinery parts and the like.
Who Should Attend: Marketing and sales persons, product engineers, managers, quality professionals desiring to expand their knowledge into the realm of medical devices made from rubber and plastic materials. Pre-requisites; general technical aptitude and general familiarity of technical terminology related to rubber and plastic materials.
- Overview of FDA and EU Regulations
- Key Definitions
- Listings and Approvals
- CE Marking, PMN(510K) and PMA( IDE)
- GMP/Quality Systems Requierements
- Common Specifications, Regulations, and Biocompatibilty Tests
- The Biomaterials Access Assurance Act of 1998 (BAAA)
- Overview of Typical Application of Polymers in Medical Devices
- Thermoplastic Elastomers
- TPVs, TPOs/Polyblends, POEs
- Block Copolymers: TPUs, SBS, SIBS, CoPA, CoPES
- Engineering Plastics
- Polyamides (nylon)
- Polyolefins: PE, PP, Cyclic Olefins
- Conventional Elastomers
- Natural Rubber and Polyisoprene (Synthetic)
- Polymer Gels
- Oil gels
- Polymer Gels
- Biodegradable Polymers
- Transdermal Drug Delivery Systems