EU MDR days to go
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EU MDR gap analysis and consulting
The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe.
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EU MDD to MDR 2017/745 gap analysis and strategy
We can perform a systematic, independent gap analysis of your CE technical documentation, procedures, and processes to help you understand what steps you must take to meet requirements of the Medical Device Regulations. Our in-depth MDR gap analysis is done by most senior consultants and includes a review of your:
CE Marking Technical File or Design Dossier
Current device class and product families
Risk management file review
Clinical Evaluation Report(s)
Labeling
Post-market surveillance (process, plan, effectiveness, PMCF, and results)
Economic Operators Agreements Review, including your European Authorized Representative (EC REP) agreement
Supply and distribution chain management procedures
Relations with your current Notified Body
Product life cycle plan
We will deliver a comprehensive report detailing deficiencies, with recommendations on how to fix them and the order in which you should address them.
CE Marking Technical File or Design Dossier
Current device class and product families
Risk management file review
Clinical Evaluation Report(s)
Labeling
Post-market surveillance (process, plan, effectiveness, PMCF, and results)
Economic Operators Agreements Review, including your European Authorized Representative (EC REP) agreement
Supply and distribution chain management procedures
Relations with your current Notified Body
Product life cycle plan
We will deliver a comprehensive report detailing deficiencies, with recommendations on how to fix them and the order in which you should address them.
EU MDR consulting
Your clinical data and Clinical Evaluation Report (CER) will face heavy scrutiny and require recurring updates. You must also fulfill increased post-market surveillance requirements, perform more Post-Market Clinical Follow-up (PMCF) studies. Titans medical can help you with this.
