Medical Devices

Medical devices sit within the miscellaneous product category. They have no pharmacological activity but are intended for human use in diagnostic and/or therapeutic fields.

With our expert global network, we support the production process of medical devices at all stages of research and development, from the preliminary safety assessment to the post-marketing evaluation phase.

SPRIM is the ideal partner to support your marketing initiatives for new medical devices, guiding you through the complex regulatory approval process. The regulatory framework could change, depending on the country and level of product-related risk. We shall work by your side, rapidly and efficiently implementing regulatory procedures, and dealing with national and international authorities. We support our consumer products:

  • by defining device specifications and clinical application descriptions;
  • by scouting scientific literature and performing documentation reviews in support of the device;
  • through product efficacy and safety research programmes;
  • with biocompatibility assessments in accordance with ISO 10993 standards;
  • with regulatory knowledge and by defining claims;
  • with medical device vigilance activities.

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