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If your device is the medical device, let's check possible classification and other conditions to meet the requirements.
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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.
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