How MDSAP Can Help you Get out of Covid-19 era Faster Than Anyone

Last time we introduce the MDSAP program. This article is the first out series of articles that will examine the process of preparing and applying for the Medical Single Audit Program (MDSAP)MDSAP can allow you to navigate your operation between regions and prepare your recovery to a full operation based on the recovery of countries

What is MDSAP?

MDSAP stands for Medical Device Single Audit Program. It was a program that was created as an alternative to FDA auditing in conjunction with international regulators. With MDSAP, there is an opportunity to participate in international auditing for five different countries. The countries include Australia, Canada, Brazil, the US, and Japan. As it relates to the current COVID-19 crisis, the MDSAP can allow you to navigate your operation between regions and prepare your recovery to a full operation based on the recovery of countries you have participated in.

The MDSAP helps to fulfill the role of providing a single regulatory audit for all medical device manufacturers’ quality management systems. Also, the MDSAP meets all the laws and regulations required in several international jurisdictions. With the MDSAP companies can develop acceptable audits by FDA standard and reduce the number of auditory inspections and expedite the recovery of your manufacturing in the sequence of the recovery of your MDSAP covered regions.

It is crucial to note that only recognized organizations can conduct the MDSAP. Likewise, manufacturing companies can choose to voluntarily join the MDSAP pilot program. The program aims to be recognized internationally for participating countries. The pilot program kicked-off in 2014 and concluded in 2016. More detail about the MDSAP pilot program will be highlighted in this series.

International Regulators: IMDRF

It is no secret that international regulators have been seeking a standardized global approach to the monitoring and auditing of medical device manufacturing companies. In the last ten years, the community of international regulations has taken significant steps to build a sustainable framework. Leveraging works from previous organizations like the Global Harmonization Task Force, the International Medical Device Regulators Forum (IMDRF) have spearheaded the efforts in the creation of this framework. As a result, they were able to develop explicit criteria for MDSAP.

To discover who is Responsible for the Creation of MDSAP and MDSAP Pilot Program see the full article here

Or set up a 15 minutes intro call here to see how you can use it in your organization.