About us

Specialized in CE and FDA for Medical Devices. We ensure compliance and offer a wide range of quality assurance and regulatory services: ISO 13485, Medical Device Regulation (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.

Get in touch with CEPK

Nordre Strandvej 97

8240 Risskov

CVR: 31689120

Phone: +45 23 29 88 08

info@cepk.dk

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15 minute free consult Check schedule for available dates

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