Seminar: Medical Device Testing Updates and Considerations
 
Seminar Date:  April 17, 2008

Location:  Toxikon Corporation
15 Wiggins Avenue
Bedford, Massachusetts
 
As safety-testing guidelines continue to be updated and revised, medical device manufacturers must address the testing requirements appropriate for their product.  With new innovations and applications in development, testing guidelines can be vague, requiring device manufacturers to implement timely and cost-effective testing programs.
 
Designed for professionals in Research & Development, Quality Assurance, Regulatory Affairs, and Design Engineering, this seminar will review considerations in ISO and MHLW biocompatibility testing, as well as recent trends in Extractables/Leachables and microbiological evaluations.

Registration
Deadline: March 31, 2008

Click for Registration Form

Agenda

8:30am-9:00am Registration and Breakfast
 
9:00am-11:00am "Biocompatibility for Medical Devices: Considerations for Medical Device Manufacturers regarding ISO 10993 and MHLW guidelines"
Laurence Lister, B.S., LATG
Director, Biocompatibility Services
 
11:00am-11:15am Break
 
11:15am-12:45pm "Material Characterization: Extractable and Leachable Study Considerations for Medical Devices and Materials"
Stephen Doherty, Ph.D.
Study Director
 
12:45pm-1:45pm Lunch
 
1:45pm-3:00pm "Microbiological Evaluation--Part 1: Validating Reusable Medical Devices- an Overview; Part II: Assessment of Antimicrobial Activity"
Sharon Malia, Ph.D.
Study Director
 
3:00pm-4:00pm Q&A
Workshops

For additional information please contact:
Joann Hoxha
Office: (800) 458-4141 ext. 132
Fax:  (781) 271-1136
Email: seminar@toxikon.com