Medical Devices

Medical Device Services

Presafe´s team of experienced compliance specialists and auditors offers you a highly skilled and cost-effective ticket to trade to the global markets.

ISO 9001

ISO 9001 certification is relevant for all sectors and companies that want to focus competitively on customer needs and product quality.

Benefits of the ISO9001 management system certification:

ISO13485 under Canadian Medical Device Regulations

Medical device manufacturers who want to access the Canadian market must, as part of the requirements to obtain and maintain a medical device license from Health Canada, be registered in accordance to ISO 13485 under the CMDCAS requirements by a Canadian Medical Devices Conformity Assessment Syst

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