Specialized in CE, FDA and UKCA for Medical Devices. We ensure compliance and offer a wide range of quality assurance and regulatory services: ISO 13485 (QMS), ISO 27001 (ISMS), Medical Device Regulation (MDR), Medical Device Directive (MDD) transition to MDR, FDA submission (510k, PMA, De Novo)...
At CEPK, we have several years of experience in regulatory affairs and perform tasks as e.g. Lead Auditor on behalf of manufacturers. We act as a link between manufacturers and notified body/regulatory authorities as we prepare manufacturers for external audits. We implement, write and review all forms of quality and regulatory documentation and ensure compliance with directives, regulations and standards.
