Health Canada has announced that they are in the process of changing from CMDCAS to MDSAP for medical device manufacturers to sell products in Canada. The Medical Device Single Audit Program (MDSAP) pilot is ongoing and was created to have a single audit meet the quality management system requirements of multiple agencies based on ISO 13485:2003. The switch to MDSAP … Read More
MDSAP Pilot
The FDA has announced that beginning in January 2014 they will begin participating in the MDSAP (Medical Device Single Audit Program). The goal of the program is “to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.” They … Read More
FDA ISO 13485 Voluntary Audit Report Submission
FDA CDRH is kicking off their ISO 13485:2003 Voluntary Audit Report Submission Pilot Program June 5, 2012. FDA wants to explore how they can leverage off of some of the ISO 13485 audits being conducted by ISO conformity assessment bodies. The premise of the 13485 Voluntary Audit Report Submission Program was based on an amendment to the law, which is … Read More