In the first part of our medical device ERP series, we covered the basics of what you should look for in a medical device ERP system. The ability to manage rapid growth, product traceability, regulatory compliance and customer satisfaction were all top of the list for an ERP system. In this second part of the series, we will be covering how to create manufacturing efficiency using medical device ERP.
Whether you are a manufacturer of medical devices or are a manufacturer providing parts for medical devices, the industry has a lot of requirements. These requirements are set in place to ensure the consumer is receiving a device that is safe to use, which is understandable, however, manufacturers are expected to meet these demands while reducing costs and lowering prices. Medical device ERP can help with this task, and many others, but how do you know which ERP system is right for your business? We’re going to take a look at the basics of what medical device ERP should do.
When it comes to choosing medical device ERP, manufacturers have a lot to put on their checklist. In such a highly regulated industry, medical device manufacturers need an ERP system that complies with FDA 21 CFR Part 11, Physician Payment Sunshine Act, cGMP CFR 820 requirements and ISO 13485. In the search to find a good medical device ERP that can comply with all those industry-specific regulations, sometimes manufacturers push other important benefits to the wayside.