With more countries adopting ISO 13485 as a requirement for medical device licensure, many are looking to the US, specifically the FDA, for their next steps with the standard.
On January 31, 2024, “the FDA [amended] the title of the regulation, and establishing requirements and provisions that clarify certain expectations and concepts used in ISO 13485:2016. The revised part 820 is referred to as the Quality Management System Regulation (QMSR).” (FDA.gov) In plain terms, the FDA has adopted ISO 13485:2016 into their requirements for medical devices and those regulations are now known as the QMSR.
What does that mean for your medical device business? QMSR requirements will go into effect on February 2, 2026. Until that point, “manufacturers are required to comply with the QS regulation” (FDA.gov). However, if you are unfamiliar with ISO 13485:2016 requirements, it is recommended that you familiarize yourself with it to best be prepared for the 2026 effective date. Implementing ISO 13485 now can ease the transition process to QMSR when new inspection processes are enacted.
As an accredited Certification Body, DQS is available and ready to speak with you about ISO 13485 and answer questions you may have about the standard, the process, and next steps. And even though the FDA is implementing QMSR regulations “to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world” (FDA.gov), it does not mean that MDR (EU) 2017/745 or MDSAP will be going anywhere when it comes to meeting requirements for countries in the EU or overseas. DQS can also assist with these regulations plus ISO 13485 to have your business ready for upcoming deadlines, whether with the FDA or the EU Commission. Contact Sales today by using the button below.
We look forward to partnering with you as you prepare your medical devices for the future.
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