Other Services

Regulatory Affairs Services

We are providing product registration support to our clients for Medical Devices and In-vitro Diagnostics in Europe and USA. Starting with a review of existing technical documentation we are defining together with your team the registration strategy. After finalizing and/or improving the Technical Documentation / Design History File we support establishing registration files / dossiers and accompanying the submission process.

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FDA Registration

For device registrations in the USA we offer our clients the preparation of all relevant documentation for FDA registrations such as 513(g), Investigational Device Exempt (IDE), Premarket Notification 510(k) and Premarket Approval (PMA).

Training

Training of personnel is vital for our client’s business success in the regulated business environment. We support establishing or improving your company’s training system for identifying the relevant training needs, training programs, monitoring of training status and we are acting as trainer and coaches of your team:

  • Class Room Training
  • Training on the job
  • Coaching of personnel
  • Basic Training Programs (see portfolio)

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