Medical devices not exempt

October 19, 2006 in Latest, News Leave a reply

RoHS can affect FDA complianceWhile, technically, they may fall under exemption EU-RoHS #8, the market-based reality is that Medical Devices and Telecom are no longer exempt from effects of RoHS regulation.
And that puts your existing FDA approval at risk.
If your company is having component issues because your suppliers are switching to RoHS (lead free) compliant parts, you are definitely not alone.

What has changed?

As component suppliers are moving towards "lead free only" and discontinuing your leaded parts, you will be faced with redesign issues, regardless of your exemption status.

China RoHS and Medical devices

China RoHS requires product marking for all electronic products beginning on March 1, 2007, including medical equipment. And unless you have supporting documentation down to the material level on all sub-assemblies, you will not survive a marking audit.

We can help

We are experts at Medical RoHS analysis and conversions 
We help keep your staff focused on future products, not redesign work, by collaborating with them to convert your existing products to be RoHS compliant, while maintaining your FDA approval status.
And we do it cost-effectively. RoHS compliance is the sole focus of Lead Free Design.
With China RoHS (which does not exempt medical devices), Korea RoHS, Australia RoHS and California RoHS programs coming, it becomes more expensive to wait.

RoHS medical deviceWhy use Lead Free Design?

We have engineering and manufacturing specialists with experience in FDA compliance, electrical and electronic design, mechanical design, plastics engineering, metallurgy, hydraulics and pneumatics. Though some engineering firms have RoHS experience, we have the FDA Medical Device expertise you require.
During the conversion process, we work closely with your team (design, verification, documentation, supply chain, testing, manufacturing), so that your RoHS documentation is always up to date and available, leaving your engineers to focus your next generation of products.

We can have your China RoHS Marking package to you in as little as two weeks. 

Read more about what we do and FDA approval

More Information
Read more – "Straight Answers: China RoHS"
Read more – "China RoHS: very different"
Read more – "The Risks of China RoHS"