Jan 30, 2017

Manufacturers struggle with how to meet new regulatory requirements with their legacy medical devices. Often companies go back to their original documentation in an attempt to provide the evidence necessary to support regulatory compliance, only to find that needed information is missing or incomplete.

In this situation, manufacturers may have people on staff who are able to talk an auditor through what they have done, and how it supports compliance with the regulations in question; however, from a regulatory perspective undocumented actions aren’t auditable. For companies to try to recreate information or create new information often requires a massive effort.

Keeping up with new regulations

Manufacturers facing remediation as a result of new regulations may find that their processes are not designed to provide the evolving level of sophistication expected. Compliance has been historically a check-the-box exercise. While this documentation may have satisfied regulators in the past, newer regulations are increasingly demanding a more complex level of interaction of both organizational functions and processes that may now operate as stand-alone entities.

Production and post-production data review is one example of a process that can, and should, provide feedback from a variety of areas and result in improved products, processes and services. As risk management becomes more mature and ingrained within organizational processes, the expectation is that companies will look at their data and try to improve product safety and effectiveness, taking appropriate actions.

Because many manufacturers are still working to implement risk management throughout their product development processes, there is still a lot of infrastructure-related work to pull production and post-production data and use it across the organization to facilitate proactive risk management, rather than strictly compliance. As a result, some companies may have to retrospectively create new structures and processes.

Linda Chatwin is Senior Customer Solutions Consultant at UL, and oversees the company’s North American Advisory Services group.


  • Linda Chatwin