CEPG Consulting

CEPG Consulting is a specialized boutique consultancy providing clinical and regulatory services to the medical device and in vitro diagnostic (IVD) industries. The firm focuses on assisting manufacturers with compliance under the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Their core expertise lies in the development of Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), and Post-Market Clinical Follow-up (PMCF) documentation. Founded by former Notified Body experts, the company provides strategic guidance on clinical evidence requirements and technical file remediation. CEPG Consulting serves a global client base, helping them navigate complex market access pathways and maintain regulatory compliance throughout the product lifecycle. The company is particularly recognized for its deep understanding of Notified Body expectations and the transition from legacy directives to current regulations.