Most Companies are Failing Their First IEC-60601-1 3rd Edition Submission
The 3rd edition updates to the standard IEC - 60601-1 are focused significantly around risk analysis, extending the application of ISO-14971 to clauses within 60601-1 itself, software under IEC-62304, and usability under IEC-62366. Both of these harmonized standards (IEC-62304, IEC-62366) are considered defacto proof of conformance to the essential requirements of the Medical Device Directive in Europe and similar requirements in the U.S. and other countries. The update also extended requirements for engineering documentation and process from system level to sub-systems within the product. Over 701 auditable clauses require the manufacturer to provide traceability of clause to document number and page for SOP’s, and in some cases, specific deliverables.
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Robust Security Planning Requires Change in Mindset
By Nicholas Daniell
Product Architects are challenged to address security throughout the device lifecycle. Read the article here...
Sunrise Golf Tournament Raises $10,000 for Joslin Diabetes Center
A HUGE THANK-YOU goes out to all who sponsored, joined, and supported the Sunrise Charity Golf Tournament. Joslin Diabetes Center received a check for $10,000!! To see highlights of the day, click here...
ON THE HORIZON
Sunrise Labs presenting:
Designing Smartphones & Tablets Into Medical Devices
San Jose Convention Center
San Jose, CA
December 2, 5:30 - 8:30
Building Intelligent Mobile Health Apps for Today and the Future
160 Trapelo Rd