"We worked with Sunrise Labs over the course of a year to design an electronic (with software), class II medical device.

Bottom line, they delivered on commitments. I was very impressed with the Sunrise team's technical skills, level of design experience, their unwavering commitment to respond to our needs, and the project leader's wisdom and leadership skills.

Together, we produced a product that sailed through FDA review and delivered 100% functionality in clinical studies."

Mike Barsness,
Senior Director of Engineering,
Transport Pharmaceuticals, Inc.


RoHS COMPLIANCE SUPPORT

Did you know…?

• RoHS rules allow you to self-certify

• CE Mark requires compliance with RoHS Directives (after deadline date)

• Specific documents can be obtained from component manufacturers to document RoHS compliance for specific parts or parts series

• Different categories of devices have different compliance deadline dates

Let us help you by…

 • Performing BOM scrub for RoHS and obsolescence using your preferred component reference tool (i.e.; Parts Miner, TPP, etc.)

• Obtaining (and organizing) IPC forms and/or Material Declaration forms from component manufacturers

• Assisting with preparing Technical File and Declaration of Conformity for CE Mark

• Working with you and your suppliers/manufacturers to meet compliance deadlines

• Establish procedures for a system to maintain compliance

 

Sunrise Labs, Inc.  603-644-4500  info@sunriselabs.com

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