QFI’s CORE COURSES

We offer training and education in compliance with medical device regulations and standards, including Council Directive 93/42/EEC, 90/385/EEC and 98/79/EC | Regulation (EU) 2017/745 and /746, 21 CFR 820, MDSAP and Data protection in just some of the following areas:

  • European medical device regulations & standards compliance and application
  • Clinical evaluation, including identification, analysis, assessment and evaluation of empirical and published data; post-market clinical follow-up (according to MEDDEV 2.7/1 and PRISM)
  • Medical device risk analysis (including EN ISO 14971 training courses)
  • Medical device single-audit programme (MDSAP)
  • Internal audit
  • Medical device file according to EN ISO 13485
  • Corrective and preventive action
  • Biological safety assessment according to EN ISO 10993-1
    • Certain courses can be offered leading to diplomas.