4 Unknown Necessities in Medical Device ERP
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4 Unknown Necessities in Medical Device ERP

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.

There are four main benefits that the right medical device ERP can give to manufacturers. When searching for a medical device ERP software, make sure they have these four functionalities.

  1. Real Time Data

    Having access to real time data increases efficiencies in medical device manufacturing and eliminates the need for manual processes. If bad parts are created and no real time data is available, you will need to do a manual inspection of all parts to determine which are unusable by the consumer. Stopping production to perform that kind of inspection eats up a lot of valuable time. Medical device ERP should have the ability to produce real time data to ensure proper manufacturing production.

  2. Historical Data

    Just as real time data is important, so is the ability to have access to historical data. Historical data will inform you of when machine maintenance is required before you run into a scenario where you start producing bad parts. A medical device ERP system that has accurate historical data will save time and money.

  3. Statistical Process Control

    A medical device ERP system should offer Statistical Process Control that helps you to analyze important process conditions and alerts you when they become out of tolerance. Statistical Process Control with these types of features will reduce the number of bad parts produced, as well as improve quality through periodically collecting data throughout the production process.

  4. Product Quality

    In an industry such as the medical device manufacturing industry, quality is extremely important. You must be able to detect whether something is wrong with a device before it is sent out to a consumer. Medical device ERP should be able to collect product quality compliance data to determine the end quality of a product. It should be able to detect variations in the process, creating less waste and less risk to the customer.

Medical device manufacturing is a process that needs to have a lot of oversight and care put into the products that are being created. A medical device ERP should be able to make this process easier and create less risk for the consumer of the device. Although it is important that the medical device ERP you choose have the ability to meet regulations, it should also be able to access real time data, historical data, Statistical Process Control and manage product quality.

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