Medical Devices No Longer Exempt
Medical devices are no longer exempt from the RoHS Directive effective 22 July 2016.
If you haven’t converted to RoHS completely, you have exposure. 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.
China RoHS and Medical devices
China RoHS required 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 a major focus of Lead Free Design.
Why 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.