Monday Feb 25, 2013

RoHS II Regulation Challenges Medical Device Manufacturers

Elmar Frühe - Master Principal Consultant, Enterprise PLM Solutions EMEA

A New Challenge

There is a new challenge making Medical Device manufacturer’s worry:  the updated RoHS regulation, now officially known as RoHS 2011/65/EU or just RoHS 2.0. RoHS regulation and the corresponding responsibility to manufacture or buy only compliant components and products is already well accepted by the Electronic and High Tech industry, but still new to the Medical Device markets.

The regulation itself becomeseffective on 2nd January 2014 and includes all Medical Devices (according legislation 93/42/EWG) except active medical implants. In Vitro Diagnostics products will follow in 2016. So the time to act is now!


RoHS II 

So what does the RoHS regulation mean specifically? First of all medical-device products have to be built without (or limited) use of certain hazardous substances like lead, cadmium or mercury. In addition the manufacturer has to prove by an adequate documentation that one is following the RoHS compliance. And last but not least there is a certificate of conformity and a CE-labeling necessary.

Every quality and regulation representative in Medical Device companies is facing a huge additional amount of work or another pile of (paper based) documentation and dossiers ready to be shipped with the product. But couldn't life be easier if software could support the overall process from a compliant design to sufficient documentation? Yes it could and the good news is that the appropriate software is there!


A Best Practice Solution

Medical Device companies using Product Lifecycle Management (PLM) software today are not nervous about the new regulation. Starting in the very early beginning of the product design they already keep an eye on being RoHS compliant while selecting only allowed components. They additionally qualify their manufacturers and suppliers as being a trustful partner providing materials and components without containing any hazardous substances. Of course all the declarations and certificates are stored as an electronic record in the system ready to be reused for any audit or technical documentation. Even new introduced parts undergo an approval process including strong supplier collaboration and collecting all signatures needed for a “Compliance OK” designation!

During the ongoing Product Lifecycle the PLM system helps to manage all the processes and information in a collaborative network. Any requirement, Bill of materials, drawings as well as schematics and layouts are managed within the system. Furthermore, they have a lifecycle status, are linked together and are change and revision controlled within the software tool. In addition, quality related processes are built in a PLM tool to manage a closed loop from a first sample inspection finding to the final corrective action and design change.

So when it comes to an audit or to the necessary RoHS documentation including product descriptions, construction drawings, compliance declarations, process plans and operation procedures, the system already has the information ready to submit or print. Medical Companies already using PLM software dramatically reduce the cost and effort of being compliant and of course mitigate the risk of launching a non-compliant product.


In Summary 

All in all PLM systems help to keep a compliant data set of records within one single source of truth – always ready to be used and managed in a collaborative network – saving time and costs, ensuring high quality and mitigating the risk of non-compliance .

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A cross industry discussion on ways to better manage product data and the entire product lifecycle from idea to end of life with special attention to the unique challenges faced by European companies.

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