Expert Clinical Evaluation Reports for MDR and IVDR Compliance
MD Compliance is Your Trusted Partner for Comprehensive MDR and IVDR Clinical Evaluation Strategy
Our Services
MDR and IVDR Clinical Evaluation Reports
Ensure compliance with the latest Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements. Our experienced team specialises in crafting thorough and compliant Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for your medical devices and in vitro diagnostic devices.
Evidence Gathering
We’ll use accepted methodologies to help you gather and analyse clinical data relevant to your medical devices and diagnostic products, ensuring appropriate literature searches are documented as the foundation for robust and comprehensive Clinical Evaluation Reports.
Post Market Clinical Follow Up (PMCF)
PMCF is a planned, proactive process to collect and evaluate clinical data on the safety and performance of a medical device, throughout its entire lifetime. We’ll help you meet PMCF requirements by:
- Assessing residual risks associated with use of your devices
- Helping you to understand and identify new risks and previously unknown side effects, including how misuse affects the safety and performance profile
- Contributing towards the update of your Clinical Evaluation Reports
- Confirming the overall safety and performance of your devices
Continuous Monitoring
Regulatory landscapes evolve. Our services include continuous monitoring of your products, providing updates to Clinical Evaluation Reports as requirements change to meet the MDR and/or IVDR.
Why Choose MD Compliance?
- Experience: Benefit from our team’s expertise in MDR and IVDR requirements, ensuring a comprehensive approach to regulatory compliance.
- Tailored Solutions: We take the time to understand the unique aspects of your medical devices and diagnostic products. Our CEPs and CERs are customized to meet the specific needs of your medical device portfolio.
- Regulatory Assurance: Stay confident in your compliance. Our services ensure that your Clinical Evaluation Reports align with the stringent standards set by both MDR and IVDR.
