Gain market access in the United States with FDA approval

Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH)

USA-flagThe United States (US) Food and Drug Administration (FDA) role is to protect public health by allowing only safe and effective products to enter the market, and by monitoring products for continued safety after they are in use.

The FDA Center for Devices and Radiological Health (CDRH) is responsible for regulating companies that manufacture, repackage, re-label and/or import medical devices sold in the US.

Medical Device Single Audit Program (MDSAP)

BSI is an accredited Auditing Organization (AO) under MDSAP. The pilot, due to finish at the end of 2016, allows manufacturers to voluntarily select to have an audit conducted by a designated AO where the audit report will be potentially accepted by five regulators including US FDA, Health Canada, ANVISA, Japan PMDA and MHLW, and TGA. 

Learn more about the Medical Device Single Audit Program (MDSAP).

What is BSI's role in global market access?

BSI employs over 120 medical device experts with experience in all aspects of the product lifecycle including research and development, manufacturing, and quality assurance. We offer specialized in-house expertise in areas ranging from sterilization processes, and animal tissue utilization to combination medical device products.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include: