The deadline for ISO 13485:2016 certification is . . . now!


The three-year transition period of ISO 13485:2016 officially comes to an end this month, but that deadline is almost meaningless at this stage. If you’re a medical device OEM doing business internationally, you have already taken the necessary steps to achieve certification for the revised global standard for medical device quality management systems. The alternative is to stop selling products in countries that recognize CE marking. Where it gets tricky is with the OEM's supply chain.

As of March 1, 2019, OEMs may not use components manufactured by "critical" suppliers that are not in compliance with ISO 13485:2016 until the non-compliance issue has been resolved, Garth Conrad, Vice President, Quality, at BD told PlasticsToday in January 2018. There is no debate on that point, but the definition of critical supplier can be elastic. Materials supplier Clariant opted to err on the side of caution several years ago. Stephen Duckworth, Head of Segment Healthcare Polymer Solutions, Mevopur, explained the process from the Clariant stand at Medical Design & Manufacturing (MD&M) West/PLASTEC West in Anaheim, CA, earlier this month.

“We talked about whether or not we should seek ISO 13485 certification with our auditor back in 2009,” Duckworth told PlasticsToday, “and we decided that we play such a critical role in the final performance of the device that our materials could almost be considered subcomponents of the device, like a plastic mold.”

Having been an early adopter of ISO 13485, it was fairly simple for Clariant to upgrade to the 2016 revision. “The good thing about having done it for so long now is that each time an auditor comes through the plant, which is every year, he or she can look at what we are doing and suggest ways we can improve,” said Duckworth.

Duckworth cites one hypothetical to illustrate the process. “The auditor might say: ‘You claim in your brochure that you can make exactly the same product to the same specification in each of your plants. Please provide documentary evidence as proof.’ So we are now into discussions about validation, a concept that does not exist in our industry but does exist with our customers. The fact that we are certified to ISO 13485:2016 implies that we always have to improve. The auditors always have to find something. And that has pushed us to up our game. We see it as a learning experience,” explained Duckworth.

The advantage for customers is risk reduction, added Duckworth. “Since we are certified to ISO 13485:2016, when our customers audit us, they immediately see that we are not at a high-risk level when it comes to their business.” Having certification at three global production sites—in Lewiston, ME; Malmo, Sweden; and Singapore—also brings Clariant a competitive advantage.

“If something were to happen at one of the facilities, two others can take its place with the same quality systems, the same raw materials, and the same production process that can be switched on the next morning. We provide security of supply,” said Duckworth.

Clariant adds that all of its MEVOPUR masterbatch concentrates and finished compounds are manufactured at the three aforementioned dedicated facilities. The MEVOPUR brand assures device manufacturers that, from USP Class VI, ISO 10993 pre-tested raw material ingredients to final product, the Clariant processes are controlled, consistent and compliant, said the company.

Image courtesy Coloures-Pic/Adobe Stock.

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