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. We work with our customers through all the steps in the process, from for example ISO13485 training and courses on MDD approval for medical devices to medical device testing and certification.

Presafe´s pre-evaluation and certification services are based on the EU Medical Device Directive, ISO 13485, the IVD directive, the FDA and Canadian medical device regulations as well as the Taiwanese regulations through the technical cooperation program between Taiwanese and European authorities. Moreover, Presafe can offer accredited certification according to the ISO 9001 standard within the medical device sector globally.

Presafe ISO13485 certification services are recognized under the Taiwan Technical Cooperation Program (TCP), which means that customers can enjoy an accelerated access to the Taiwanese market. Presafe can also help customer meet Canadian medical device regulations through CMDCAS certification and its partnership with SAI Global.

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