+39 06 5782665
contact@donawa.com

REGULATORY AND QUALITY

Training

Donawa Lifescience Consulting (DLC) offers training on a variety of subjects pertaining to US and European regulatory and quality system requirements for medical devices. These sessions are designed to be interactive and can be conducted either at client facilities, or at the DLC office in the historic centre of Rome. The following topics are currently available, but please contact us if you have specific requirements:

  • 510(k) Submissions; Traditional, Abbreviated, Special, and De Novo
  • US Quality System Regulation (QSR) (US 21 CFR 820)
  • Medical Device Reporting (MDR) Requirements (US 21 CFR 803)
  • Medical Device Corrections and Removals (US 21 CFR 806)
  • FDA Medical Device Quality System Inspection: Things To Do Before, During and After an Inspection
  • The CE Marking Process under the new Medical Device Regulation
  • European Clinical Data Requirements, including Clinical Evaluation
  • European IVD Medical Device Requirements under the new IVD Regulation
  • European Medical Device Post-market Requirements
  • European and US Requirements for Software Contained in Medical Devices
  • European and US Clinical Studies and IVD Performance Evaluations
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