Meet Your Regulatory Compliance Requirements

How a Product-Centric Quality Management System (QMS) Improves Control, Traceability, and Compliance

How to Reduce Obsolescence Risks

Component databases can also help with obsolescence. Choosing the right components is critical to ensure parts can be sourced locally and globally as needed. Unfortunately, many medical device companies still don’t have a scalable method to identify electronic parts for functionality, availability, and compliance. Modern component databases can help gain visibility when components are going end-of-life, and thus avoid part shortages during volume production.

Being caught unaware on a part going EOL can be catastrophic, causing production and shipping delays.

Reduce Obsolescence Risks

Imagine having a medical device that you expect to last for three to four years. It’s working well in the market and its components are readily available, but suddenly one part goes obsolete. Because of a single component, your ability to produce and ship products is at risk.

Now, you might need to find a similar part that meets your cost, compliance, and functionality goals—which is not always possible. So, you are almost certain to increase costs, delay shipments, and/or build products that are not capable of meeting the performance objectives of your original design. For regulated medical device companies that produce Class II or Class III devices, the latter is not going to be an option.