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Pre-conference workshop: An introduction to Biocompatibility
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Pre-conference workshop: An introduction to Biocompatibility
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9:00am-10:00am60
mins
Registration
10:00am-10:10am10
mins
Workshop introduction
- Sharlene Dai,Medtronic
10:10am-10:50am40
mins
Biological safety of medical devices from the engineering product life cycle perspective (design, material, manufacturing, sterilization, packaging, to the final finished device
- Mike Ebert-Sr. Therapy Delivery Engineering Manager,Medtronic Restorative Therapies Group
10:50am-11:15am25
mins
Morning coffee
11:15am-11:50am35
mins
Biological evaluation best practice within risk management framework (plan, testing, report to submission)
- Sharlene Dai,Medtronic
11:50am-12:25pm35
mins
Biological tests: protocols to reports
12:25pm-1:00pm35
mins
Experts panel discussion Q&A
- Thor Rollins-Director of Toxicology and E&L Consulting,Nelson Labs
1:00pm-2:00pm60
mins
Lunch
2:00pm-2:45pm45
mins
Chemical characterization - Extractables and leachables testing (study design, protocol, identification and report)
- Siyi Zhang-Principal Chemist,, Medtronic Restorative Therapies Group
2:45pm-3:05pm20
mins
Afternoon refreshments
3:05pm-3:35pm30
mins
Toxicological risk assessment
- Sharlene Dai,Medtronic
3:35pm-4:15pm40
mins
Experts panel discussion
- Siyi Zhang-Principal Chemist,, Medtronic Restorative Therapies Group
- Sharlene Dai,Medtronic
4:15pm-4:20pm5
mins
End of workshop
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