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Medical Devices Compliance

Critical issues facing Medical Device in 2020: Pre-market pathways, MDR & MDSAP Implementation, Marketing Off Label Use

Summary

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 of the pre-market hurdle. On the other hand, the EU’s new regulation 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. The MDR imposes many new requirements, one of which is the mandatory renewal of your exported device’s CE mark every ten years. This means that life cycle programs for devices will change. 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. 

Areas Covered in the Session

  • Identify applied qualifications for 510(k) self-certifications
  • Explain global inspections per FDA 13485
  • What to expect for EU inspections by a Notified Body
  • Changes in FDA’s regulation of software and cybersecurity threats
  • Identify the impact of the EU’s MDR on U.S. device exports
  • Explain the role of Affirmation of Compliance submissions for imports
  • Analysis off-label marketing and intended use parameters

Who should attend?

  • Product VP, Director
  • Regulatory Affairs Directors
  • Quality Assurance Managers
  • Quality Control Managers
  • Manufacturing Directors and Managers
  • Product Risk Managers
  • Venture Capitalists
  • Medtech Startups
  • CEOs and Founder, MedTech
  • Domestic device manufacturers
  • Design engineers
  • Business planning executives
  • Foreign and domestic regulatory affairs managers
  • Quality assurance managers – foreign and domestic inspections
  • Logistics managers
  • Manufacturers of exported devices
  • Export Distributors
  • Initial importers
  • Import Logistics Managers
  • Foreign Manufacturers
  • U.S. Manufacturers
  • Import-for-export Manufacturers
  • Sales and marketing directors
  • Customs Brokers

Casper Uldriks

Expert

Casper (Cap) Uldriks, brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. 

He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. 

Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

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