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Medical device importation

Biostar was created with a clear international outlook; as such, we offer our clients assessment and support in medical device importation, particularly with respect to regulatory compliance at each stage of the medical device development process required to obtain the CE mark.
Our experience and accreditation endorse our reputation as industry experts in healthcare regulatory procedures and quality management systems based on ISO 13485, so we can advise and guide any company that requires support with medical device regulatory affairs in order to meet both national and international standards.