MCRA’s consultants are experts in achieving success with global regulatory bodies. Our team has industry leading experience with global regulatory strategy and deep understanding of the IVD lifecycle. We provide strategic support through the development process, including conception and design considerations, analytical and clinical performance testing, regulatory application, and commercialization. Providing clients with the best-in-class representation to regulatory agencies.
Contact an IVD Device Global Regulatory Expert
Global IVD Device Regulatory Services
MCRA’s team has successfully navigated hundreds of international regulatory submissions. Our capabilities extend to European, Australian, and Canadian markets, successfully remediating Technical Documentation and Performance Evaluation Reports (PER) for compliance with the EU In Vitro Diagnostics Regulation (IVDR, (EU) 2017/746) for IVDs.
MCRA has industry leading specialization in the full spectrum of IVD medical devices. Over the years, we have supported hundreds of clients seeking regulatory designations, approvals, and international registrations with Technical Documentation and PERs for Global markets.
MCRA is a world-class provider of regulatory strategy and consultancy services for IVD medical devices. Our comprehensive regulatory services from design, development, registration and post-market activities include:
- Regulatory landscape assessment
- Global regulatory strategy
- Due diligence services
- Device classification
- Technical Documentation gap assessment
- Performance Evaluation planning
- Establishment registration
- Scientific validity assessment
- Analytical Performance plan and reporting
- EU Technical Documentation and Performance Evaluation Reports (PER) compliant to the EU IVDR
- Labeling compliance activities
- Agency/Notified Body submissions/responses
- Post-market surveillance plans and maintenance activities
- Quality system gap assessment
- Mock audits
- Medical device reporting
- Regulatory file letters
- Device listing
- Import/export
- Training (EU IVDR)
For further information on our related services, please follow the below links: