Medical Device Services

IVDR Consulting

Navigating the EU’s In Vitro Diagnostic Regulation (IVDR) is complex, with heightened requirements around performance evaluation, clinical evidence, classification, and post-market obligations.

EU MDR Gap Analysis

Whether transitioning from MDD to MDR or seeking to optimize your existing processes, our EU MDR Gap Analysis identifies weaknesses and develops action plans aligned with current regulatory expectations.

Clinical Evaluation Reports (CERs)

We offer expert CER writing services in accordance with EU MDR requirements and MEDDEV 2.7/1 Rev 4. Our team ensures each Clinical Evaluation Report is scientifically robust, properly referenced, and defensible to Notified Bodies.

Post Market Surveillance (PMS)

Property Crime

Our Post Market Surveillance (PMS) services help you meet MDR and IVDR requirements while improving patient safety and product lifecycle management. We support PMS planning, data collection, and reporting activities tailored to your device risk class.

Post-Market Clinical Follow-up (PMCF)

PMCF is a core part of the MDR’s clinical evidence framework. We help you develop and implement PMCF plans and reports that support ongoing safety and performance evaluations in real-world use.

Medical Device Consulting

From concept through post-market, Precision Clinical Services provides comprehensive medical device consulting aligned with EU MDR, FDA, and global regulations. Our consultants offer technical and strategic expertise across regulatory, clinical, and quality domains.

At Precision Clinical Services, we are dedicated to driving progress in healthcare by supporting pharmaceutical, biotechnology, and medical device companies with expert-led clinical and regulatory solutions.