2-day In-person Seminar

Critical Issues for Medical Devices in 2020

Director :
Casper Uldriks

Date: January 30th & 31st, 2020
Time: 9:00 AM to 6:00 PM
Location: Boston, MA
Venue: Embassy Suites Boston Logan Airport
Download:  Seminar Brochure

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Course "Critical Issues for Medical Devices in 2020" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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.

Learning Objectives:

  • Identify applied qualifications for 510(k) self-certifications
  • Explain global inspections per FDA 13485, the EU Medical Device Regulation (MDR) and the Medical Device Single Audit Program (MDSAP)
  • What to expect for EU inspections by a Notified Body
  • Identify the impact of the EU's MDR on U.S. device exports
  • Analysis off-label marketing and intended use parameters
  • Joint federal agency enforcement for false and misleading information
  • Identify the changes in FDA's regulation of software, jurisdiction and cybersecurity

Who Will Benefit:

  • Domestic device manufacturers
  • Design engineers
  • Business planning and marketing executives
  • Foreign and domestic regulatory affairs managers
  • Quality assurance managers - foreign and domestic inspections
  • Logistics managers
  • Devices Exporters
  • Export Distributors
  • Initial importers
  • Import Logistics Managers
  • Import-for-export manufacturers

Day 1 Schedule

9:00 a.m.

Registration, personal introductions and morning refreshments

9:00 a.m. - 10:30 a.m.

Current FDA statutory requirements and device regulatory program changes

FDA premarket and postmarket initiatives

  • Self-certification for software and class II devices (EU MDR 2020)
  • Voluntary standards (abbreviated premarket submissions) (FDA)
  • Premarket inspection priorities (FDA)

10:30 a.m. - 10:45 a.m. Break
10:45 a.m. - 12:00 p.m.

Premarket continued

  • EU 10-year premarket renewal requirement for devices
  • Impact of new MDR clinical study reporting requirements on foreign IDE clinical sites

12:00 p.m. - 1:00 p.m. Lunch
1:00 p.m. - 2:30 p.m.


  • Unified U.S., EU and Canada inspection program
  • Tougher postmarket reporting for adverse events (EU and FDA)
  • FDA software, software-based devices and mobile apps

2:30 p.m. - 2: 45 p.m.Break (refreshments)
2:45 p.m. - 4:30 p.m.

Postmarket (continue)

  • FDA software, software-based devices and mobile apps
  • Cybersecurity oversight and voluntary standards

Day 2 Schedule

9:00 a.m. - 10:30 a.m.

Export of devices from the U.S.

  • Export of unapproved PMA devices to the EU under MDR 2020
  • Export of 510(k) devices not cleared for marketing to the EU under MDR 2020
  • Export of approved PMA or cleared 510(k) devices
  • "Tier 1" countries for global commerce

10:30 a.m. - 10:45 a.m. Break
10:45 a.m. - 12:00 a.m.

Import considerations

  • Domestic and foreign marketing cautions
  • Affirmation of Compliance for U.S. entries and Prior Notice
  • Voluntary Qualified Import Program (VQIP)
  • Detentions and Refusal

Changes in software regulation and cybersecurity requirements

12:00 p.m. - 1:00 p.m. Lunch
1:00 p.m. - 2:30 p.m.

Off-label determinations of intended use and off-label intended use

  • Intended use creep (incremental expansion) and indications for use
  • FDA determination for acceptable vs. unacceptable claims for intended use
  • Contradictory labeling prohibitions (Where you are located makes a difference.)
  • Off-label device distribution
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Casper (Cap) Uldriks

ex-FDA Expert and former Associate Center Director of CDRH

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.

Location: Boston, MA
Hotel: Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA

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