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PMCF Bundle template for MDR 2017/745

CHF75.00

The Medical Device Regulation MDR 2017/745, Annex 14, B defines requirements for manufacturers to conduct post-market clinical follow-up studies for higher classed medical devices. Find here the template bunlde for the PMCF plan and report. The bundle is delivered as:

  • Word file format
  • Contains plan and report template
  • Requirements per MDR 2017/745

PMCF Report template for MDR 2017/745

The Medical Device Regulation MDR 2017/745, Annex 14, B defines requirements for manufacturers to conduct post-market clinical follow-up studies for higher classed medical devices. Find here the template for the PMCF report. The report is delivered as:
  • Word file format
  • Requirements per MDR 2017/745

PMCF Plan template for MDR 2017/745

The Medical Device Regulation MDR 2017/745, Annex 14, B defines requirements for manufacturers to conduct post-market clinical follow-up studies for higher classed medical devices. Find here the template for the PMCF plan. The plan is delivered as:
  • Word file format
  • Requirements per MDR 2017/745
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Description

The MDR 2017/745 defines in its Annex 14, B the requirements for a Post-Market Clinical Follow-Up (PMCF) for higher class medical devices. Find here the templates in a bundle to cover the aspects of a PMCF plan and report.