Medical Device Certification Adds Value
GRAND RAPIDS — Quality management system requirements for medical device manufacturers are complex, and each new product must meet rigorous regulatory standards before entering the market. With the growth of that sector, the interest in ISO-13485:2003 certification appears to be on the rise, too.
ISO-13485 is an international medical device manufacturing certification that meets the quality system requirements of the global medical device industry and addresses most Food and Drug Administration requirements, as well.
“One of the big things that ISO-13485 focuses on is making sure that you’re aware of all your regulatory requirements and have a process to meet them,” said Brandon Kerkstra, owner and president of Management Solutions Group, a consulting firm specializing in ISO-certification readiness. Management Solutions has helped nearly 200 Midwest companies — from small tool and die suppliers to Fortune 500 companies — prepare for different types of ISO certification.
Grand Rapids-based Ranir LLC sought the certification as a means of adding value to its products, which include a wide range of oral care devices. Some 85 percent of its products are manufactured in Grand Rapids.
A lot of companies seek ISO-13485 certification so they can sell outside the United States, specifically in Europe, and that was Ranir’s motivation, as well. The certification has opened up the European medical device market for Ranir, allowing for the company’s first foray into a market outside North America. That was a necessity, said Jeff Fisher, Ranir’s vice president of technology and product development, because over the years Ranir had come to dominate the U.S. market. In order to maintain its aggressive growth strategy, the company had to look for new markets in the United States and new markets abroad, he said.
“We’re not the lowest cost provider of materials, so we need to go to markets where we can effectively leverage our quality and service story — and Europe is a good one for that,” Fisher observed. “Europeans are used to shopping for high-quality, high-service products.”
Fisher said Ranir isn’t interested in being the lowest cost supplier in the United States. The company wants to sell its U.S. customers on the quality of its products and services, and ISO-13485 is a Cadillac-level of certification that its competitors don’t typically bring to the table.
Ranir was the first company Management Solutions Group assisted through the ISO-13485 registration and certification process, though the company has prior experience in medical device standards, Kerkstra noted. The entire process took about eight months.
Kerkstra said Ranir already had a very good system to start with, as far as the management process. Management Solutions looked at the procedures Ranir had in place, added the ISO-13485 requirements for design and risk analysis, and made sure all the regulatory requirements had been looked into and documented, Kerkstra said. The process included regular project team meetings and staff training.
As with other ISO certifications, companies are required to train all of their employees on the parts of the new system that have changed and that affect them directly. Next, there is an internal audit of the system, and lastly, a registrar must conduct a final certification and grant certification. The British Standards Institute granted Ranir the ISO-13485 certification.
Training is ongoing, and registrars visit one or twice a year to conduct surveillance audits to verify that the formal process is still being followed, and that it’s still effective. As procedures change, people have to be retrained. Training is now an everyday event at Ranir, Fisher noted.
According to Kerkstra, even companies like Ranir that have good, solid quality management structures to start with, in many cases can still experience efficiency gains.
Fisher said the concern going into the certification process was that it would require everybody to do a lot more work.
“In fact, I think we’re seeing the opposite,” Fisher remarked. “Because our systems are better codified and better documented, we’re able to do the same job much more efficiently than we did before. Every development or design project follows essentially the same scheme and generates the same documents, which has made us a much more efficient company in product development.”