Clinical Evaluation Procedure Bundle
Connect medical device clinical evaluation, post-market clinical follow-up (PMCF), post-market surveillance (PMS) and clinical investigation with five editable products in one digital download.
What is included
Clinical Evaluation Procedure: scope, evidence appraisal and analysis through the Clinical Evaluation Report (CER), including an instructive CER report document.
Post-Market Clinical Follow-Up Plan: objectives, methods, responsibilities and timing for planned clinical follow-up activities.
PMCF Evaluation Report: evaluation of follow-up findings, conclusions and proposed actions.
Post Market Surveillance Procedure: broader surveillance planning and reporting, including a sample PMS plan.
Clinical Investigation Procedure: investigation planning, conduct and records, with a clinical investigation plan and report, investigator brochure, site forms, informed consent material and case report form guidance.
The investigation plan, report and investigator brochure described above are documents within the included Clinical Investigation Procedure download. They also have separate standalone listings.
When to choose the bundle
Choose the bundle when you need the connected procedures and documents across this clinical evidence workflow. The PMCF Plan defines the intended follow-up work, the PMCF Evaluation Report evaluates its findings, and the Clinical Evaluation Procedure connects the evidence to the continuing evaluation. PMS brings in broader post-market information; the Clinical Investigation Procedure supports planning and conducting investigations.
If you need only one part of the workflow, use the individual product links above to compare its scope and price. Check documents you already own before purchasing.
Download and implementation
Supplied as editable Microsoft Word documents with related forms in a digital download. The included clinical-evaluation documents address Regulation (EU) 2017/745 (EU MDR). Adapt the documents to your devices, evidence needs, responsibilities and working practices. Review the previews and individual product descriptions before purchasing.
Bundle value
The five included products currently cost $595 when purchased individually: Clinical Evaluation Procedure $149, PMCF Plan $49, PMCF Evaluation Report $49, Post Market Surveillance Procedure $149 and Clinical Investigation Procedure $199. This bundle is $499, saving $96 (approximately 16%). Related forms are included as described above.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Clinical Evaluation Reports: Turning Medical Device Evidence into Conclusions for workflow guidance, a checklist and common mistakes.
