Post-Market Clinical Follow-Up (PMCF)
The EU MDR mandates that manufacturers gather clinical data after market launch through a Post Market Clinical Follow-Up (PMCF) process. This complements pre-market clinical evaluation and ensures safety and performance in real-world conditions.
Apotech can support with:
- PMCF plan development
- Literature review and data interpretation
- Protocol and statistical analysis plan development
- PMCF study report preparation
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Featured case studies
EU-MDR Technical File Authoring
EU-MDR Technical File Authoring Introduction Medical Technology Client Our client is a leader in high-quality, surgeon-designed, innovative ophthalmic products located in the US with operations globally. These range from Class I through to Class III devices. Apotech Consultants Our consultants take a risk-based approach to improve quality and compliance, and implement practical solutions for your…
A genetic testing kit manufacturer Journey to UKCA Marking with Apotech
Introduction The client In response to the UK’s new post-Brexit regulatory requirements, our client, an innovative genetic testing kit manufacturer, collaborated with Apotech to achieve UKCA marking. This strategic move was aimed at maintaining their market presence in the UK, ensuring uninterrupted access for their cutting-edge products. Types Scope of work Apotech provided end-to-end support…
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…