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Services for PMCF and related areas

Do you need ad-hoc or continious support to fullfill the MDR requirements or to optimize your work?

I provide high quality support (e.g. with documenation, strategy development) at 145 CHF

Post-Market Clinical Follow-up (PMCF)

Typical deliverables:

  • PMCF plan and report in line with MDR Annex XIV Part B, MDCG 2020-7

  • PMCF strategies for products including gap analysis of existing PMCF activities and remediation roadmaps

  • Support with various PMCF data collection methods and procedures (studies, surveys, registries, user feedback, general activities etc.)

  • Preparation and support for notified body audits

Interactions with Clinical Research, Clinical Evaluation, Post-Market Surveillance and Risk Management

Typical deliverables:

  • Input for evidence generation from clinical studies

  • Review of study protocols and reports for PMCF and other MDR relevant information and ISO 14155 conformity

  • Report clinical data in CERs, SSCPs and PSURs

  • Review relevant sections in the Clinical Evaluation and Post-Market Surveillance documentation

  • Input for process alignment with the different functions

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