Market Access & Compliance Services

To enter US, Canadian, Brazilian, Japanese, or Australian markets you will need be in compliance with Medical Device Single Audit Program (MDSAP) requirements. MDSAP enables a certification body to perform a single regulatory audit of your company to ensure you comply with the relevant requirements of the participating regulatory authorities. We will conduct a gap analysis on your Quality Management System (QMS) to identify any non-conformities before producing a report you can use to upgrade your QMS or if you prefer, we can complete this project on your behalf.