Are you prepared for IEC60601 Edition 3?
Can you answer “YES” to these questions?
- Do you have an ETL, CSA, UL or TUV mark that will need to be updated?
- Does your design history file address all of the required normative standards?
- Is your risk management file updated to comply with ISO 14971?
- Does your verification document adequately address all risk items in your spec?
- Do your validation documents comply with IEC62366 (Usability Engineering)?
- Does your software design documentation comply with IEC62304?
- Are there any new guidance documents you now need to comply with?
- Does your plan include sufficient time for 3rd party testing?
- Do you have the internal capacity to get your product and documentation ready for 3rd party testing to the updated standard?
If not, we can help you comply with IEC60601 Edition 3!
“We engaged StarFish to review and update our product and documentation for IEC60601ed 3 and we are very pleased with the results. The level of expertise and professionalism provided has made StarFish one of our favorite and versatile vendors”
Patrick Rimroth, GM Mizuho OSI, Union City, CA
StarFish can provide a comprehensive review of your Design History File to highlight any weak spots in your preparation for ISO 60601 Edition 3 (learn more about our QMS-in-a-Box):
- in depth onsite review for 2 days at your facility
- 2 days of internal expert review
- 20 page detailed report
- only $4995