Our Experts

OFlaherty Neil O’Flaherty has been a principal with Olsson Frank Weeda Terman Matz PC since 1997 and concentrates his practice on U.S. Food and Drug Administration regulation of medical devices. Mr. O’Flaherty has counseled numerous clients on legal and policy issues related to medical devices. He acts as a liaison with FDA on behalf of clients, and researches and analyzes complex and sophisticated matters for clients.

For Mr. O'Flaherty's full professional biography, click here.

Neidlemen Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration.

For Mr. Neidelman's full professional biography, click here.

Wong Jack Wong has nearly 20 years of experience in regulatory affairs, clinical trials and postmarket vigilance, much of that focused on medical devices. Formerly head of regulatory affairs at Johnson & Johnson Medical, he currently serves as director of regulatory affairs, Asia Pacific, at Terumo BCT. Mr. Wong has played a leading role with the Asian Harmonization Working Party, and has also worked with ASEAN, APEC, ISO and the World Health Organization. In 2007, he launchedthe first course to certify regulatory affairs professionals in Asia; it has since graduated more than 1,500 students. Mr. Wong founded ARPA, the Asia Regulatory Professional Associations, in 2010, and the Asia GRP (Good Regulatory Practice) Research Centre the following year. He is the author of Handbook of Medical Device Regulatory Affairs in Asia.
DuVal Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. 

For Mr. DuVal's full professional biography, click here.

Bos Dr. Gert W. Bos has 21 years of experience in lifesciences (devices and pharma) in university and industry, as well as four notified bodies. Dr. Bos holds is head of regulatory and clinical affairs at BSI Healthcare (NB0086 / NB0535) and is head of notified body at BSI-Germany (NB0535). He is president of the notified body association TEAM-NB, vice-chair of the medical notified body forum in Brussels, NB-MED, and participates in the Notified Body Recommendation Group (NBRG), the Clinical Investigation and Evaluation Group (CIE), Medical Device Expert Group (MDEG) and a number of MDEG workgroups. He is one of the regulators representing Europe in the IMDRF Workgroup on Regulated Product Submissions. He is a founding member of the Dutch RAPS Group. Dr. Bos holds a PhD from Twente University of Technology in the Netherlands.

Neidlemen Marlon Burgess is a 20-year veteran of South Africa’s device industry, having worked with both large multinationals like Johnson & Johnson’s Ethicon, Philips and Stryker, and start-ups like Dinaledi Medical, which he took from a zero sales base to R100 million annually in three years. He currently is the CEO of MDG Health Solutions, specializing in business development and sales and marketing. Marlon is also the chairman of the board and chair of the Health Policy and Government Relations Committee at the South African Medical Device Industry Association, and a member of the South African Laboratory and Diagnostics Association.