EU MDR Requirements (GSPRs)
Quality Management Systems (QMS)
EU MDR Gap Analysis (QMS, TDs, CERs, PMCF Plans)
Clinical & Regulatory Strategy Development
MDR Technical Documentation (TDs)
EU MDR Clinical Data Sufficiency / Gap Analysis
Clinical Evaluation Reports (CERs)
Clinical Investigation / Protocol Development
Post Market Surveillance (PMS) and Post Market Clinical Follow Up (PMCF)
Summary of Safety and Clinical Performance (SSCPs)
EU MDR Training
EU MDR Notified Body Compliant Templates
EU MDR Compliance Audits
Notified Body Responses / Communication and Liaison
Risk Management & Mitigations Under EU MDR
General EU Market Access & CE Marking Support
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