Medical devices: show your credentials with ISO 13485
Faulty defibrillators in Belgium, the international PIP breast implant scandal, the “Implant Files” affair… Medical devices provide countless services, but their use is not without consequences. From design to end-of-life treatment, all those involved must take certain precautions. These precautions are described in ISO 13485, the quality management standard for medical devices on which the certification of the same name is based. A sign of quality that is highly recommended if you operate in this market estimated at 28 million euros for 1,300 manufacturers in France and 10,000 product categories.
How to implement the latest version of ISO 13485: 2016?
Hip prostheses, heart valves, insulin pumps, condoms, contact lenses and dental crowns, not forgetting measuring devices such as scanners, right down to the software they integrate… All players in the medical device value chain can claim to be ISO 13485-compliant.
As of March1, 2019, only the latest version of this standard is authoritative: certifications granted on the basis of versions prior to 2016 are invalid. So you need to migrate your processes to the new repository. The level of requirements assessed by our auditors is rising very significantly,” warns Aude Leroy, ISO 13485 Product Manager at AFNOR Certification. To support this move upmarket, AFNOR Certification has set itself a requirement: to distribute this certification with COFRAC accreditation [accreditation n°4-0571, available at www.cofrac.fr ]. We obtained it for the latest version, that of 2016. “Since then, AFNOR Certification has also obtained approval to distribute the CE mark for medical devices [mise à jour du 3 juin 2024].
Why get ISO 13485 medical device quality management certification?
ISO 13485 certification is a traditional counterpart to the CE mark , which is required by all manufacturers marketing medical devices. “Today, users of medical devices (EPHAD, CHU, etc.) welcome it as a sign of confidence that helps them sort out the market. A defibrillator maintenance service, for example, can hardly intervene without the company supplying it holding the certificate,” explains Aude Leroy.
The icing on the cake: ISO 13485 certification means you’re on track for upcoming regulatory deadlines. ” European regulations 2017/745 (for medical devices, including active implantables) and 2017/746 (for in vitro diagnostic devices) require manufacturers to demonstrate to auditors that they control risks throughout the life cycle of the medical device, in 2020 and 2022 respectively. By presenting their ISO 13485 version 2016 certification, they are reassuring their customers of their ability to control risks. “argues Aude Leroy.
These regulations raise the quality management system requirements for these devices, including a requirement for post-purchase monitoring. By the same token, ” the notion of continuous traceability is at the heart of the new version of certification, which will be assessed by our auditors “, sums up Aude Leroy. Is certification a sign of presumed regulatory compliance? Yes, and several years ahead of schedule!
