Mitigating Medical Device Product Liability Risk

Product liability lawsuits may be a stark reality for medical device manufacturers, but a comprehensive medical ERP could be the solution

Product liability lawsuits are a stark reality for medical device manufacturers.

When there is so much at stake (ultimately, the risk of damage or even loss of human life), there is an onus on medical device manufacturers to ensure the safety and reliability of their product quality at all times.

With medical device recalls almost doubling in the US over the past decade, it is almost impossible to keep faulty products away from consumers.

All this, despite the FDA apparently working to ensure only “safe” products are made,  and a dedicated effort from manufacturers to keep harmful devices out of the marketplace.

Unfortunately, liabilities with medical device product could occur at any one of three phases of the product life cycle:

1. Design
2. Manufacturing
3. Marketing.

For medical device manufacturers, defects occurring at the manufacturing stage are usually the easiest to prove.

In this whitepaper from IQMS (which became DELMIAWORKS following the acquisition by Dassault in 2019) you’ll discover how, and why, a comprehensive ERP (enterprise resource planning) system could be the solution for manufacturers looking to mitigate the risk of product liability:

• Automated: with an automated process, you remove the risk of human error
• Comprehensive: by tracking every single detail of production (including things like temperature, cycle time and other process parameters) and making sure you trace the entire life cycle of each and every finished product and component (from start to finish), product liability risk is greatly reduced.

With a comprehensive and automated ERP software system, you are able to prove, beyond the shadow of a doubt, that the part or device has been manufactured correctly. This proof gives you the mitigation against product liability risk that you need.

You can find out more about IQMS EnterpriseIQ (now known as DELMIAWORKS) ERP software & MES systems here.

 

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