Process Validation

The FDA expects medical device OEMs to exercise a high level of process control whether their products are manufactured in-house or outsourced. Process validation is a methodology that manufacturers use to provide objective evidence that a process consistently results in a product or outcome that meets specifications. A reliable, validated process produces increased yields and ultimately impacts the quality of the finished product.

For these reasons, the FDA requires manufacturers of medical devices to perform process validation on any process associated with the finished product—but not necessarily the components within the product, like printed circuit board assemblies (PCAs). While the FDA does encourage the use of process validation on PCAs, it is not mandated. Anyone familiar with the thoroughness of an FDA investigation knows that a medical device manufacturer's liability will not end simply because PCAs are exempt from the process validation requirements. Every responsible medical device manufacturer, whether they produce finished medical devices or just supply components to the medical device industry, must demonstrate that all their internal processes are optimized and controlled—something we've been doing at Paramit for years.

As an FDA-registered manufacturer of finished medical devices, Paramit consistently performs process validation on all medical products we build. We are also a supplier of PCAs to our internal operations and to OEMs that build products in-house. Our experience has shown that PCA process validation not only improves yields, but also decreases board rework, which in turn improves the long term reliability of the board. PCA process validation also provides baseline information that's critical to uncovering the root cause of product failures that are linked to defective boards. Consequently, Paramit has adopted a strategy of performing process validation on all PCAs and supplying the process data to the OEM—just in case.

The bottom line for every medical device OEM is this: if the FDA discovered an issue, would your current PCA vendor pass scrutiny? At Paramit the answer is yes.