top of page

Medical Device Conformity Assessment Services

Product Conformity Assessment involves testing and certification processes to show that your product, service or system meets the requirements of a standard. It demonstrates that a medical device is designed and produced to be safe, fit for purpose and perform as intended.


At Wiselink, we are able to identify the most suitable product quality standard on an international scale for your medical device. We will organise testing and certification with the corresponding regulatory authority. By choosing Wiselink, you will receive reliable consultancy and efficient services.


The benefits of undergoing a medical device conformity assessment:


  • Provide consumers and other stakeholders with added confidence

  • Give your company a competitive edge

  • Help regulators ensure that health, safety or environmental conditions are met

  • Gain market access to your intended country of import and/or export

Looking for the right PCA for your medical device? Contact us today!

bottom of page