When

Friday, May 17, 2019 from 8:00 AM to 5:00 PM EDT
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Where

6800 N. Chestnut St, Ravenna, OH 44266 
 

 
 

Contact

  Christie Robinson, M.Ed.
  Director of iLearn Innovation Institute                        ACE Products & Consulting LLC 
  234-254-1821 
  christie.robinson@aceprodcon.com 
 

Introduction to Rubber and Plastic Medical Device Regulation and ISO 13485 

This is an introductory course is intended for rubber and plastic material suppliers and for manufacturers who supply medical device marketers. The course intends to provide attendees with a global view of what is involved in being involved in the medical device supply chain including understanding of key terminology, standards, and approval processes.  The key elements of the course include US FDA Quality Systems regulation 21CFR820, ISO Quality Management Standard 13485, the material biocompatibility standards ISO 10993 and USP Class 6. Using practical examples such as exam gloves, PEEK spinal implants, and polyurethane catheters; the presenter demonstrates the use of the internet and FDA web site to determine device classification, approval process, and material or part test requirements.  

Tour: There will be an optional tour of the ACE Products & Consulting LLC facility during the day.

Cost: $725

Instructor: David Russell, Consultant

Hotel Information: ACE Products & Consulting LLC has a negotiated rate of $119 at the Kent State University Hotel & Conference Center. You can call the hotel directly at (330) 346-0100 or reserve online at www.kentstatehotel.com and use promotion code ACE for our rate.

Instructor Bio:

Dave Russell is a graduate of the University of Akron where he studied Engineering, Mathematics, Chemistry and Polymer Science.  Dave has worked in the polymer industry for over 40 years working for companies like Goodyear Synthetic, Eaton Corp, Akron Rubber Development Laboratory Inc, Akron Polymer Laboratory Inc, Smithers Scientific Inc, Citrics Biomedical Inc, Biomerics LLC, Theken Spine LLC and Integra Life Sciences Inc. 

Dave’s has extensive experience an all levels of business from bench chemist to CEO operating: materials R&D labs, compounding plants, polymerization units, quality organizations and entire businesses.  After 15 years with Eaton’s Engineered Polymer Products Division he returned to UofA to study Polymer Science then in 1992 formed Akron Polymer Laboratory Inc. 

In 2003, after selling Akron Polymer Laboratory Inc, Dave formed Akron BioMaterials Inc. a business specializing in medical grade polymeric materials.  Most recently, Dave sold the assets and know-how of Akron BioMaterials Inc to Biomerics LLC a supplier of medical grade polymerics, catheters, and injection molded products. 

Dave’s bibliography includes multiple patents and publications in the areas of polyurethanes, high energy radiation crosslinking, spine implants, bone grafts, nano- materials, and anti-microbials.