In the many years that I have been covering the medical manufacturing supply chain, I have occasionally come across contract manufacturers who make a virtue of not having ISO certification. These are outliers, to be sure, but they claim that the added cost and complexity of jumping through quality systems certification hoops is not worth it. The proof? Their business with medical device OEMs is going along quite nicely without it. There are always exceptions to the rule, but most medical molders that I have spoken with are skeptical.
"The level of quality required depends on the application and the level of risk," says Bob Welch, Chief Technology Officer at Phillips-Medisize (Hudson, WI). "Medical tubing may have a much lower risk than a complete plastic device that is made up of 14 or 15 parts and may even contain some metal inserts. But, generally speaking, without the appropriate certification, you are limiting your potential customer base. It's on their checklist—ISO 13485 is always required by our customers," says Welch.