$297 — Premium Tier

Clinical Evaluation & EU MDR Toolkit: CER, PMCF & Biocompatibility

Complete clinical evaluation toolkit with CER templates, PMCF plans, biocompatibility assessment, and EU MDR Article 61 compliance guidance.

Get the Toolkit — $297

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What's Included

Clinical Evaluation Plan (CEP) Template
Clinical Evaluation Report (CER) Template
Literature Search Protocol
Literature Appraisal Checklist
Equivalence Assessment Template
Post-Market Clinical Follow-up (PMCF) Plan
Biocompatibility Evaluation Plan (ISO 10993-1)
Biological Risk Assessment Template

Benefits

CER structure accepted by Notified Bodies
Systematic literature search methodology
Clear equivalence demonstration
Integrated biocompatibility assessment

Is This For You?

This toolkit is designed for teams facing these challenges:

CER rejected by Notified Body
Literature review methodology questioned
Equivalence arguments are weak
Biocompatibility evaluation incomplete

Who This Is For

RA professionals writing CERsCompanies seeking EU MDR certificationClinical affairs specialists

Frequently Asked Questions

How long should a CER be?

Depends on device complexity. Simple devices: 30-50 pages. Complex implants: 100+ pages. Quality over quantity.

Do I need clinical trials?

Not always. Many devices can rely on literature and equivalence. Templates help determine if clinical data is needed.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $297

7-day money-back guarantee