ERP Requirements Analysis for Medical Device Manufacturers

Medical device manufacturers have some ERP requirements at the top of their list that might be considered of lesser priority at another type of manufacturer. Many of these requirements are quality related as these medical devices businesses are almost always tightly regulated by one or more government agencies.

Quality Planning

Nearly all ERP systems have the ability to check off whether an inspection is passed or not. Medical device manufacturers will often look for the next threshold, a quality plan. A quality plan allows the user to design specific steps to be included in an inspection.

These steps can be qualitative, such as whether a C of C is included from the supplier. A simple yes or no answer is filled in. They can also describe, in detail, specific measurements to be taken along with the ability to enter those measurements directly within the ERP. Now those measurements can be analyzed from the same database as all other ERP-collected data. The measurements can also have limits and an alert when a measured value is high or low.

User Certification

Most ERP systems capture transactions in detail with an audit trail showing the user and time stamp for every transaction. A medical device manufacturer might need their ERP to go beyond that basic level and monitor if the user is qualified for a particular operation or inspection based on training, testing, or experience.

A medical device manufacturer might need their ERP to go beyond that basic level and monitor if the user is qualified for a particular operation or inspection

For example, if the user’s certification requires an annual renewal, the user and the supervisor will be notified in advance by the ERP system and the user will not be allowed to process certain transactions after the renewal date.

Supplier Management

Supplier management is another area where a medical device manufacturer will want a little more from their ERP system. The particular certifications a supplier might hold can be an integral part of the company’s government certifications. The medical device manufacturer might not have a specific kind of manufacturing in their core competency, meaning outsourced competency is required for approval of their device. Often the reporting requirements to maintain government approval are very specific so the capability of the ERP reporting process is also very important.

ERP Platform & Vendor Choices

Medical device manufacturers are often small start-up businesses, founded by an individual with an idea. They will be watching cashflow very closely and ERP in a SaaS environment can be critical to allow business growth.

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The business itself can be risky if the founder has used personal wealth to capitalize the business. Limiting additional risk be selecting an ERP provider with a good track record and a top-tier balance sheet is important. And, as the business is small and possibly without an IT staff, the ERP provider should have fast and reliable support available as needed.

Medical device manufacturers have requirements much like any manufacturer but with particular emphasis on a few domains that might be less important to another business. Make sure you factor these areas into your requirements analysis and don’t lump yourself in with the rest of the manufacturing industry.

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Tom Miller

About the author…

Tom completed implementations of Epicor, SAP, QAD, and Micro MRP. He works as a logistics and supply chain manager and he always looks for processes to improve. He lives near San Francisco Bay in California and can be found on the water in his kayak or on the road riding his motorcycle. Contact Tom at

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Tom Miller

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