Strategic PMCF Consultancy
Services for Post-Market Clinical Follow-up (PMCF) and related areas.
Flexible and reliable support for medical devices manufacturers to meet the requirements of the EU MDR
About me | Evelyne Buehler
I have over a decade of experience in the clinical department of a medical device manufacturer (Institut Straumann AG). Developing strategies and finding solutions is my passion. IÂ set up the post-market clinical follow-up unit including establishing procedures and templates and defining the PMCF strategy across the product portfolio (class I to class III devices). Before PMCF I managed clinical studies and I was involved in collecting and raporting various types of PMCF data (studies, surveys, registries)
Services
Post-Market Clinical Follow-up (PMCF)
Continuous clinical evidence generation after market placement — planned, executed and documented so that it stands up to notified body scrutiny.
Typical deliverables:
• PMCF plan and report (MDR Annex XIV Part B, MDCG 2020-7)
• PMCF strategies and gap analysis
• Data collection support
• Audit preparation
Interactions with Clinical Research, Clinical Evaluation, PMS and Risk Management
Optimize collaboration between functions and ensure alignment in the product documentation to avoid unnecessary questions from Notified Bodies.
- Typical deliverables:
• Evidence generation input
• Protocol and report reviews (ISO 14155)
• Data reporting in CERs, SSCPs and PSURs
• PM/PMS documentation review
• Cross-functional process alignment