Medical devices are defined by the US Food and Drug Administration (FDA) as “any object or component used in diagnosis, treatment, prevention, or cure of medical conditions or diseases, or affects body structure or function through means other than the chemical or metabolic reaction in humans or animals.”
Under this definition, a medical device could be anything from tongue depressors to CAT scanners. Due to this wide variety of items and equipment classified as medical devices, the FDA has no single standard to which a specific device must be manufactured. Instead, they have created an all-encompassing guide that every manufacturer must follow.
Devices are classified into three classes:
- Class I, which includes devices are the least likely to cause major bodily harm or death in the event of failure (think tongue depressors, for example), are subject to less stringent regulations (General Controls) than devices categorized as Class II or Class III.
- Class II devices are subject to General Controls and Special Controls.
- Class III devices are subject to General Controls and Premarket Approval.
One key element in the manufacture of any device (yes, even tongue depressors), is the ability to track a lot and serial numbers, from the source of every component at the beginning of the supply chain, to the delivery of the finished products at various destinations.
Enterprise Resource Planning (ERP) systems that integrate lot and serial number tracking as part of their application are therefore best suited for medical device manufacturers. It’s not rocket science, but even so, some ERP systems have tracking capabilities and some don’t.
That’s where Strategic System Group (SSG) comes into this picture. We work with just about every manufacturing ERP software solution available on the market today. We even continue to support some legacy ERP systems that are no longer available. SSG is uniquely positioned to help medical device manufacturers choose the ERP solution that will meet both their manufacturing and their regulatory requirements.
Save yourself the headache of reviewing a dozen options. With 27 years of experience in implementing and supporting manufacturing ERP software solutions, SSG will pinpoint the one that’s just right for you, from among the many systems we support:
- Microsoft Dynamics
- AX, NAV, GP, and Dynamics 365 for Financials and Operations
- ERP LN, Baan, MK, and Manman
For more information, call Strategic Systems Group at 310.539.4645 or email us at email@example.com. We look forward to speaking with you soon.