Manufacturing/Production Stage

Until recently, a typical medical device manufacturing team worked (for the most part) independently of regulatory affairs. If manufacturing wanted to machine a part instead of forge it, or change to a different supplier, they did so without perceiving the need to notify anyone in regulatory affairs. But in today’s tightly regulated medical device environment, that independent decision-making can have severe repercussions for a medical device company.

Change control has become a major sticking point with the FDA and with international governments. Even the smallest, most seemingly insignificant change could actually shut down a company’s business in parts of the world. RA has the insights to help ensure that any medical device-related change will adhere to both U.S. and global regulatory requirements, which is why it’s vital for manufacturing and regulatory affairs to work collaboratively.

The level of involvement, control, and notification that is required depends on the type of device, its classification, where and how it is marketed, and a host of other factors. For example, a U.S. medical device manufacturer selling a device in another country may need to notify that country’s regulatory agency if it wanted to move an operation to a new facility or supplier. In addition, because most regulatory agencies expect high-level change control detail, it’s possible that the authorities not only would require the company to notify them of such a change, but to halt imports of any products into the country until the appropriate documentation has been reviewed and approved. The RA team is equipped to help manufacturing navigate these complicated regulatory nuances so work can be completed with as little disruption or risk to the company as possible.