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There’s a lot of technology, both software and hardware, driving the modern medical industry. All of that equipment has to be up to a strict set of regulatory standards, not just in the end user stage — where they’re in medical facilities being getting used in the field — but all the way starting at the manufacturing stage.
That’s where this week’s community question comes from. Bob S. asks, “Researching our next generation ERP / MRP application for use in a medical device manufacturing shop environment. FDA & ISO13485 level of quality system. Currently using Epicor Vista 8. Is there a better solution?”
For clarity’s sake, let’s first examine the regulatory standards that cover the medical device manufacturing sector.
There are a variety of different domestic and international standards for medical device manufacturing. In the U.S. the main regulatory body is the Food & Drug Administration, who standardize device manufacturing under the umbrella of general medical device regulation.
Domestic (U.S.) FDA Standards:
The International Organization for Standardization (ISO) publishes standards for everything from film stock to banking to formats for digital data storage. Most often organizations will work towards compliance in whichever standards pertain to their sector and then apply for official ISO certification in said standards.
There are two ISO standards specifically pertaining to medical device manufacturing:
Many general manufacturing ERP solutions on the market that can cater to the special needs of the medical device manufacturing niche, regulatory compliance included. Here are three standouts:
If you’re still looking for additional information on the best software to potentially manage a medical manufacturing business, or any discrete manufacturing processes in general, your best resource is going to be our Business-Software.com Top 15 Discrete Manufacturing Software report.
From there, try exploring our comprehensive manufacturing software resource page, where we compile all related blog content, premium offers and manufacturing product profiles.