The FDA's device regulation has begun to make your regulatory life easier. Can you qualify for an easier way of life under FDA regulation? Getting to market with a new device could be totally under your control and keep FDA out the premarket hurdle. On the other hand, the EU's new Medical Device Regulation (MDR) will make it more difficult. How can you prepare for that? What does it mean for FDA's regulatory plans and your marketing roll out for new products? One disaster remains hidden and will be costly if you do not plan for it.
The new EU Medical Device Regulation (MDR) affects U.S. firms that export devices to the EU. In addition, the MDR imposes many new requirements such as the mandatory renewal every 10 years of your exported device's CE mark. The CE renewal is not a rubberstamp process. It requires an assessment of performance and safety based on a ten-year look. Information before the 10 years limit is not acceptable.
Life cycle evaluation for devices will change. Post market surveillance, clinical experience reports and real-world evidence have become a critical component of EU's device program. How will this impact your regulatory compliance?
These are questions you should be able to answer to adequately your firm for 2020, not just in the U.S. but in the EU as well.
The Notified Bodies will perform very thorough inspections and make unannounced inspections. Now that they have liability for their work, they will take the extra step to make sure your manufacturing and management system are acceptable.
Finally, the Medical Device Single Audit Program (MDSAP) is underway with the goal of making inspections of multiple regulatory bodies consolidated into one inspection, which reduces the burden of that work on manufacturers and creates greater uniformity among the participating countries.
Registration, personal introductions and morning refreshments
Current FDA statutory requirements and device regulatory program changes
FDA premarket and postmarket initiativesPremarket
Export of devices from the U.S.
Changes in software regulation and cybersecurity requirements
Off-label determinations of intended use and off-label intended use
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Casper (Cap) Uldriks through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. He served as a senior manager in FDA's Office of Compliance at and as an Associate Center Director for regulatory guidance and government operations in the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements, such as FDA's import/export program. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters. Licensed to practice law in Massachusetts and Washington D.C.