Market Access and Compliance
Medical Device Single Audit Program (MDSAP)
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.
We can assist you in gaining access to a wide range of markets globally including, but not limited to the following: