Obscure but Effective Regulatory Pathways for Devices

Overview:

The entire world today engages regulations, whether these are by means of their own national laws, standards or requirements or else by means of borrowing the regulations of other nations that are deemed acceptable in their own right, in order to allow a medical device manufacturer to introduce a product into any market.

Why should you Attend: Within the regulated world of medical devices, there exist numerous opportunities to introduce a product for specific claims in advance of broader desired claims, as well as lesser claims in advance of greater, more compelling claims. Likewise, there exist numerous opportunities to pursue advanced claims without delay, with the proper communication at the beginning of the process.

Areas Covered in the Session:

• Old but Effective Regulatory Pathways
• Old and Ineffective Regulatory Pathways
• New, lesser known FDA Pathways
• Techniques and Tactics in Corresponding that Regulators will appreciate
• New, lesser known Foreign Market Pathways
• Speedy Pathways in the USA
• Speedy Pathways Outside of the USA
• Harmonization versus Sequence of Submissions (MDSAP/STED v. alternative)
• Policies (written and unwritten)

Who Will Benefit:

• Regulatory Management
• Regulatory Consultants
• Quality Management
• Sales & Marketing Management
• Scientific Staff (Advisors)
• Clinical Staff (Advisors)
• Research & Development Management

Speaker Profile
Shep Bentley is the President and Principal Consultant for Bentley Biomedical Consulting, LLC, where he is responsible for regulatory strategies leading to FDA approvals and clearances for digital medical device companies. Shep began his career in 1984 at the Hospital Corporation of America as a research technician, and worked at McGaw Labs in Irvine, responsible for GMPs until 1989, when he joined TOSHIBA America where he managed production of various digital devices. He founded Rising Star, a contract manufacturer for digital medical assemblies in 1993, and sold it in 1997 to Standard Industries in Anaheim.