EU MDR Requirements (GSPRs)
Practical, evidence-based support tailored to your device and submission stage.
EU MDR Advisory Services
Obtain your CE-marking goals efficiently with former Notified Body professionals.
Our Proven EU MDR Experts Can Help
Support ranging from focused gap analysis to complete submission development and Notified Body response management.
MDR Technical Documentation
Practical, evidence-based support tailored to your device and submission stage.
Post-Market Surveillance and PMCF
Practical, evidence-based support tailored to your device and submission stage.
EU MDR Compliance Audits
Practical, evidence-based support tailored to your device and submission stage.
Quality Management Systems
Practical, evidence-based support tailored to your device and submission stage.
Clinical Data Sufficiency / Gap Analysis
Practical, evidence-based support tailored to your device and submission stage.
Summary of Safety and Clinical Performance
Practical, evidence-based support tailored to your device and submission stage.
Notified Body Responses and Liaison
Practical, evidence-based support tailored to your device and submission stage.
EU MDR Gap Analysis
Practical, evidence-based support tailored to your device and submission stage.
Clinical Evaluation Reports
Practical, evidence-based support tailored to your device and submission stage.
EU MDR Training
Practical, evidence-based support tailored to your device and submission stage.
Risk Management and Mitigations
Practical, evidence-based support tailored to your device and submission stage.
Clinical and Regulatory Strategy
Practical, evidence-based support tailored to your device and submission stage.
Clinical Investigation / Protocol Development
Practical, evidence-based support tailored to your device and submission stage.
Notified Body-Compliant Templates
Practical, evidence-based support tailored to your device and submission stage.
EU Market Access and CE Marking Support
Practical, evidence-based support tailored to your device and submission stage.
25+Years of engineering experience
25+Years with Tier-1 Notified Bodies
400+Clinical Evaluation Reports
300+Conformity assessments