Management Insights, Traceability and Auditing for Medical Device Manufacturers

By Scott Frappier | May 2, 2019

As a key decisionmaker in your organization, one of your many jobs is to stay up to date on incredibly fast-moving technologies available for your medical device business. Regardless of how “technical” you are, that’s a big job -- and we’re here to help. This 3-part blog series is designed to help you get clear on how technology supports mission-critical business functions for your organization.


Heavily regulated products like medical devices require comprehensive audit trails of every single element of the development of the device. Reliable traceability allows for teams to access and analyze every change made during the development, including minute specifics about what the changes were when they occurred, who made them, who authorized them, and why they were necessary.

For our medical device clients, traceability is mission critical. The medical device industry is inherently risky. Failures represent very real, very high stakes, and literal lives can be affected. Integrated, systematized traceability provides reports on requirement modifications directly to affected team members in real-time, and in a single interface, allowing for quick action and reliable data.

It’s not a matter of IF there will be a failure of some sort with your device, it’s when. And medical device companies that don’t use traceability place themselves at much higher risk without it. The solution we recommend brings track and trace data into a single interface, providing faster and more efficient interaction with the information. In the case of a recall, integrated traceability means that just the affected lots need to be recalled, versus all lots. Workers can zero in on the specific quality control issue that led to the recall and remediate it quickly.

Example: A hearing aid manufacturing company gets feedback that the microphone is failing. This report, by the way, can come from customers if the product is in the market already, or it can come from one of their engineers in the development process. Either way, the ability to immediately identify the materials in that particular lot throughout every single step of the supply chain is not only important to keep the business profitable and operational, but it’s also a regulatory requirement. Even the most meticulous quality systems have shortfalls and adding this layer of cost-effective risk mitigation into your system provides supplementary support, compliance, and peace of mind.

Traceability for the Marketing Team (Sales Audit)

A side benefit to having integrated traceability is insight into customer behavior. You can easily see which customers have which versions and lots of the product. You can identify a set of customers who are ready for upgrades and see which customers returned products. You can use this insight to return to customers and ask for feedback on the product, and more. This information can easily integrate into your CRM system

Internal audits are a reality of medical device manufacturing companies. Are you ready? The right solution provides you a dashboard that, at the click of a button, provides every detail requested in the audit Pick the Right Partner. Have you fully vetted the partner for their integration chops?

Why it matters: Other companies will tell you they know how to integrate your disparate systems, but that very much depends on how much experience they have with the technology, the depth of their understanding of the medical device manufacturing “language” you speak, and so many more variables. Getting the integration right, without breaking what you currently have in place, is essentially important.

Why Stoneridge?

The reason we at Stoneridge Software are able to reliably connect internal systems is that we work with the most stable, state of the art business tools from Microsoft. We have deep expertise in these tools AND the medical device manufacturing niche. We make a plan and work with what you have, so nothing breaks during the transition. Our goal is to keep you fully operational while we improve your internal business processes with integrated systems! Our deep institutional expertise with Microsoft’s business tools and with medical device manufacturing, so we’re able to help our customers upgrade information systems without churn and with a fully vetted plan.

Contact us to learn more or download our white paper for comprehensive technology recommendations for your medical device business.

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