Leveraging Your NSF Certification: Now that you've received NSF Certification ... why not leverage the Mark to your advantage.
By James Pink, Partner, Medical Devices, NSF-DBA, part of NSF International Health Sciences Division
October brought together some of the highest profile names in medical device material safety as specialists from NSF Health Sciences global medical devices teams hosted an interactive study day on the biological evaluation of medical devices at our Sheffield, UK facility.
Discussions were led by representatives from both U.S.-based NSF Pharmalytica and UK- and U.S.-based NSF DBA. Invited speakers included Albrecht Poth, Chair of ISO Technical Committee 194 (Biological Evaluation), and John Lang, NSF-DBA Associate and EUROTOX Medical Device Toxicologist and Convener of WG14 Material Characterization, ISO TC 194.
Discussions focused on the changes to the ISO 10993 and regulatory interpretations of biological evaluation since the high-profile cases concerning metal-on-metal implants as well as the PIP breast implant cases. Representatives of both SGS and BSI notified bodies were on hand to aid in discussion.
We designed NSF Health Sciences medical device study days to ensure the latest interpretations, scientific opinions and regulatory expectations are discussed in a balanced way enabling manufacturers to gain the most up-to-date knowledge and participate in the formulation of future actions.
“Very good course, fairly priced and informal, with sensible responses to questions. We (industry) need more seminars like this.” – James Bradbury (Summit Medical, UK)
“Fascinating day for someone new to the medical device industry. Great experience to learn from experts within the industry.” – Izzy Bud (Brightwake, UK)
“Great to have such an applicable event put on locally; excellent expert panel.” – Sarah Carpenter (Smith & Nephew, UK)
“The NSF-DBA Medical Devices study day allowed me to see that others in the industry have similar questions on the increasing regulatory requirements. The guest speakers provided clear and concise subject matter encouraging planting-of-seeds for the pathway forward in the different projects that the attendees are involved in.” – Janine Oxley (Oxley Medical, UK)
Topics for upcoming study days in 2013 include:
Contact James Pink, jp@nsf-dba.com, for dates and locations of upcoming study days.