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The Medical Device Single Audit Program (MDSAP) is a new initiative that could help you satisfy multiple regulatory requirements with a single audit. Read on to see if this program is right for your business and what you need to do to prepare.

One Audit to Accommodate Multiple Legislations

The MDSAP is a program that allows a single regulatory audit on a medical device manufacturer’s quality management system to satisfy multiple regulatory jurisdictions. One audit, conducted by authorized Auditing Organizations (A0), checks for compliance against up to five different medical device markets, including Australia, Brazil, Canada, Japan, and the United States. The program was created in response to increased global trade in the medical device sector and works to leverage resources and create a more efficient and effective audit program.

Advantages of the MDSAP

If your company is based globally and exports products into the participating countries, MDSAP makes good business sense. The program provides improved transparency and helps manufacturers better prepare for audits, eliminating the ability for each legislator to have a different approach. It also can ease entry into some markets, particularly Canada. In fact, if you aren’t currently in the Canadian market MDSAP will be a requirement if you want to enter.  Additional benefits of MDSAP include:

  • Minimized disruptions: Fewer regulatory audits and inspections minimize disruptions to your operations.
  • Predictive audit schedules: From the initial certification audit of your quality management system to surveillance audits to the recertification audits, you will know what to expect and when to expect it.
  • Reduced time and costs: One audit will save both time and resources both during the audit process and if you need to deal with findings. There is also a cost saving when comparing one audit with one AO to performing multiple independent audits.

Depend on Experience

MDSAP can provide significant advantages for device manufacturers who are able to participate in the program. But finding a partner who understands the specific challenges and opportunities of MDSAP and has experience working with the program are keys to success. If you’re considering participating or would like to discuss if your medical device company is ready for MDSAP contact us today.