All IVD products marketed in the EU must meet the new IVDR regulation by May 2022. With the end of 5-year transition period for compliance on the immediate horizon, it is imperative for manufacturers to begin the process of implementing the mandated requirements.
Your Partner for IVDR Compliance
Beaufort is ready to support all facets of your IVDR implementation. Our specialized IVDR team members are subject matter experts that understand the complex details, regulatory expectations and new mandatory requirements. With Beaufort by your side, you have access to the expertise and tools needed to reach full compliance, including:
Comprehensive IVDR Services
Beaufort can provide the strategic and technical guidance to develop an appropriate project plan, as well as assist with the implementation of any stage of the IVDR certification process.
QMS / Risk Management
- Strategy for Regulatory Compliance
- IVDR-Specific QMS Changes
- Classification & Conformity Assessment
- Other EU IVD Directives & Regulations
- Risk Management Evaluation Criteria /
- Benefit Risk Analysis
- IVDR Readiness Audits
Clinical Evidence
- Guidance on New Clinical Evidence Requirements
- Legacy Product Data Review
- Performance Evaluation Plan / Report (PEP/PER)
- Analytical Performance Report
- Clinical Performance Plan / Report
- Clinical Performance Study Plan (CPSP)
- Scientific Validity Report
Labelling & UDI
- Intended Purpose / Claim Review
- Labels & Instructions for Use Requirements
- Applicable Standards
- UDI Requirements & Symbols
Technical Documentation
- Technical Documentation Review & Preparation
- GSPR Gap Assessments & Traceability Matrices
- Test, Hardware, Software Requirements
Post-Market Surveillance / Vigilance
- Post-Market Surveillance Plan / Report
- Post-Market Follow-up (PMPF) Plan / Report
- Incident Reporting
- Periodic Safety Update Report (PSUR)
Economic Operators / EUDAMED
- Person Responsible for Regulatory Compliance (PRRC)
- Registration of EO’s & Devices
- Control of Suppliers (Process/Method)
To speak to an IVDR expert, or if you don’t see the services you are looking for, contact us at [email protected].