Let's check if your device is a medical device in your market area.
If your device is the medical device, let's check possible classification and other conditions to meet the requirements.
Registration services are available!
Key expertise area box
EU: MDR 745/2017
USA: FDA CFR 21 §820
Canada: HC SOR/98-282
Quality Systems: ISO 13485
Risk management: ISO 14971
Basic safety and EP: IEC 60601-1
EMC: IEC 60601-1-2
Other world-wide Regulations&Standards
Who is Jouni Karkinen behind Karkinen.com?
Experience from Datex Div, Instrumentarium Corp
Experience from GE Healthcare
Experience from KaVo Kerr
Over 20 years of experience in Medical field.
Please, contact with this form or send an email to email@example.com