About
Specialized in CE, FDA and UKCA for Medical Devices and AI products. We ensure compliance and offer a wide range of quality assurance and regulatory services: ISO 13485 (QMS), ISO 27001 (ISMS), ISO 27701 (PIMS), ISO 42001 (AIMS), Medical Device Regulation (MDR), Medical Device Directive (MDD) transition to MDR, FDA submission (510k, PMA, De Novo), EU AI Act... 🅱🅾🅾🅺 𝗮 𝗺𝗲𝗲𝘁𝗶𝗻𝗴 👉🏻 https://cepk.dk
Technologies
Gmail
Google Apps
Google Font API
Mobile Friendly
Keywords
medical equipment manufacturing
iso 42001
iso 27701
uk medical device regulation
medical devices
medical device regulation
external audits
ce certification
ai product compliance
consulting
iso standards
other scientific and technical consulting services
regulatory documentation
regulatory compliance
b2b
risk management
eu ai act
iso 13485
healthcare
mdr transition
notified body list update
fda submission
compliance
fda 510k
ukca certification
iso 27001
borderline cosmetic products
services
quality assurance
hospital & health care
Company Information
-
Employees 2
Location
97 Nordre Strandvej, Aarhus, Central Denmark Region, Denmark, 8240
