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 at 145 CHF (or equivilant in other currency) per hour for:
Post-Market Clinical Follow-up (PMCF)
Typical deliverables:
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PMCF plan and report in line with MDCG 2020-7, MDCG 2020-8 and MDR Annex XIV Part B
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PMCF strategies for products considering relevant guidance documents
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Support with various PMCF data collection methods and procedures (studies, surveys, registries, user feedback, general activities etc.)
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Consultancy for procedures and templates
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Preparation and support for notified body audits
Interactions with related areas such as Clinical Research, Clinical Evaluation, Post-Market Surveillance and Risk Management
Typical deliverables:
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Consultancy for evidence generation from clinical studies
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Review of study protocols and reports for PMCF and other MDR relevant information and ISO 14155 conformity
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Report clinical data in CERs, SSCPs and PSURs
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Review relevant sections in the Clinical Evaluation and Post-Market Surveillance documentation
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Consultancy for process alignment with the different functions
Do you need other services/ support or have any questions?