ComplianceOnline Announces Interactive Workshop on Medical Device Premarket 510k Submissions
ComplianceOnline, the leading GRC advisory network, and well known regulatory affairs expert Dr. David Lim, will conduct a day long, interactive workshop on premarket 510(k) notification submissions for medical devices.
- Aguadilla-Isabela-San Sebastian, PR (1888PressRelease) August 04, 2012 - Palo Alto, CA, USA - ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced an interactive workshop on Premarket [510(k)] Notification Submissions. The day long workshop led by regulatory affairs expert Dr. David Lim will be held on October 31, 2012 in San Francisco, CA.
This workshop is intended to provide guidance on how to format 510(k) submissions including necessary contents to proactively facilitate the FDA review process for medical devices including in vitro diagnostic devices. The course has been pre-approved by RAPS and participants will be eligible to receive up to 6 RAC credits toward their certification on completion.
For more information or to register for the seminar, please click here.
Seminar instructor Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia. Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., a Luminex Company. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.
During this interactive seminar, Dr. Lim will provide insight the various federal statutes and regulations governing medical devices in the US. Participants will get a full and thorough understanding of the 510(k) format and content for various device types, including in vitro diagnostic devices.
This seminar will be valuable for anyone in the FDA-regulated industry, including, but not limited to, medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This workshop is a must for those directly or indirectly involved in 510(k) submissions. In addition, this workshop will also be very beneficial to those preparing for and handling conformity assessment applications for CE marking purposes.
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