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Public Training Course Dates & Information:

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On-site TrainingOn-site Training

A customizable, cost-effective solution for groups of 5 or more. Contact us to learn more »

On-site TrainingGroup Discount Save up to 25%

Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training

Obtain product approval and gain a competitive advantage in the US and/or EU

How can you get your medical device to market in the US or EU? Learn about the available options and how to use strategic thinking to make a sound decision for your company. Interactive discussions and workshops allow opportunities to practice applying the course concepts.

You’ll explore questions such as:

  • When is a product regulated in the US/EU and why does this question matter?
  • What are the available pathways to market?
  • What should I consider when I assess the paths to market?
  • Are there any options that might present an "easier" way to get to market?
  • When is it advantageous to talk to FDA before a formal submission?
  • What impacts the review time – and what can I control?
  • When would it make more sense to enter the EU before the US?
  • What are some best practices that improve the submission development process and the overall submission?

Highlighted Handout

  • Matrix of EU Annex I Requirements (MDD Essential Requirements Compared to MDR General Safety and Performance Requirements)

Learn more about how Oriel STAT A MATRIX can help you during the 510(k) submission process or to attain your CE Mark.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.888.532.6360  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Edison, NJ 10/23/2018 3 $2895.00 Add to Cart CONTACT US
Boston, MA 01/15/2019 3 $2895.00 Add to Cart CONTACT US
Chicago, IL 03/05/2019 3 $2895.00 Add to Cart CONTACT US
San Diego, CA 05/07/2019 3 $2895.00 Add to Cart CONTACT US
Orlando, FL 06/11/2019 3 $2895.00 Add to Cart CONTACT US
San Francisco Area, CA 07/30/2019 3 $2895.00 Add to Cart CONTACT US
Minneapolis, MN 09/10/2019 3 $2895.00 Add to Cart CONTACT US
Edison, NJ 11/12/2019 3 $2895.00 Add to Cart CONTACT US

Objectives

  • Identify the US FDA pathways to market as well as their advantages and disadvantages.
  • Apply a strategy to choose an appropriate regulatory pathway.
  • Describe how to establish substantial equivalence for a 510(k) premarket notification.
  • Identify the necessary sections of a 510(k) premarket notification.
  • Explain the role of the CE Mark in the EU.
  • Describe EU device classifications and pathways to market.
  • Identify the necessary sections of a Technical File.
  • Identify the impact of the new EU device regulations (MDR and IVDR) and preparation challenges.
  • Describe regulatory submission best practices.

Topics

  • US device classification
  • US regulatory submissions strategy
  • US pathways to market, including 510(k) premarket notification, De Novo, and PMA premarket approval
  • EU CE Marking
  • EU Directives (MDD, AIMD, IVDD) and EU regulations (MDR, IVDR)
  • EU device classification
  • EU conformity assessment routes
  • Technical Files and Design Dossiers

Who Should Attend

Medical device quality and regulatory affairs professionals with a need to understand how to select an appropriate regulatory submission/clearance pathway for a medical device in the US and/or the EU.

Number of Days: 3
CEUs: 2.5
On-Site Training Close

The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.888.532.6360 or Contact Us.

Get answers right now. Call 1.888.532.6360