FDA – Approval for medical devices

Due to its purchasing power, the US market is one of the most important global markets for medical products. All medical products that are to be sold in the USA must meet the strict requirements of the US Food and Drug Administration (FDA).

Our seminar series familiarizes you with the necessary basic knowledge of FDA requirements and the prerequisites for access to the US market.

The seminar contents

  • Legislative and regulatory overview
    • Overview of the legislation
    • Organization of the FDA
  • General FDA requirements
    • Registration and listing
    • Submission
  • Access to the US market
    • Product classification
    • Investigational Device Exemption (IDE)
    • Premarket Approval Application (PMA)
    • 510(k) Premarket Notification
    • Labeling/UDI
  • Postmarket requirements
    • Medical Device Reporting
    • Recalls
    • Device Tracking

Your trainer

Dr. Cornelia Luban, Qserve Group Deutschland GmbH

Information about our trainers

Costs

1 day in-house training: Euro 3.790,- (excl. VAT) for max. 10 participants; incl. seminar documents and certificate of attendance, plus travel expenses.

Book now:

Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491