Dear Sarah
You have posted your question more than a year ago, so my reply might not interest you anymore, but it looks like you are logged in today, so here is my opportunity to went :mg:
I'm a regulatory affairs person for a small Canadian medical device manufacturer, and I'm in this field for more than 15 years. I've never felt this much frustration doing my job EVER!
We are developing a class II low risk device and currently seeking the 4th quote for the 60601-1 3rd edition testing - trying every lab in the Toronto area.
The best quote so far (after weeks of haggling) is $41,000.00 !!! In my previous job (in the era of 2nd edition) a very-very similar device's testing used to cost 5-$6000.00, they are in the market place for years and they proved to be safe. The 3rd edition introduces a level of requirements that is bordering paranoia frankly, but more to the point is a very blunt instrument with very little room to distinguish between real safety concerns. Is it an MRI machine or a blood pressure monitor? Doesn't matter, let's go through all 396 pages plus collaterals. And the testing labs taking advantage of this aspect.
Here are my real-life experiences and the factors contributing to my extreme frustration:
- every testing lab is avoiding to give you even a tentative quote, before extensive checklists and component details - they have to know your device, fair enough; yet after all the details we give, they come up with set prices, especially for collateral standards, all of a sudden totally ignoring the specifics of the device. Case in point: I've pointed out to one of them, that form 45 clauses in a collateral standard 20 is not applicable to my device, 5 are a repeat from another collateral, 14 requires a simple inspection of the labeling and ONLY 4 requires them to execute technical testing requiring their laboratory settings. It doesn't matter the price is stuck at $8000.00
- the checklists for Risk Management the labs are giving out are all different, some are outdated (the latest lab asked me to fill out a table running on 31 pages which was based on the 60601-1 TRF (test report form) version G (when in fact is version H is now in effect) based on ISO 14971:2000 not matching the latest ISO 14971:2007 which is the harmonized standard by now
- these RM checklists are de facto doing most of the labs' job to review my Risk Management, yet for this item alone I get quoted 7-$8000.00
- in order to facilitate the labs job of risk management review, our Risk Management Report morphed into a monster document, becoming unreadable, full of NA's, and addressing issues which for all practical purposes don't have anything to do with the actual device, but is a clause in 60601-1
- our device has an inert USB powered "dummy" hardware component with the real brain (and innovative aspects) incorporated in the software part; 60601-1 has 5 pages on the subject (clause 14 PEMS), delegating this whole issue to other standards (life cycle, architectural design, software verification, etc), testing labs having precious little to do with any of it, yet THIS IS MY DEVICE!
And then the finale: when I face my Notifying Body, my risk management will be scrutinized thoroughly AGAIN - this time on it's merit (I have been there, I know), namely the software development cycle, software testing, requirements traceability, usability, etc; great focus will be on clinical validation. The "Colours of the insulation of conductors" or the outcome of a push-test will be absolutely non-essential and not touched-upon with good reason.
So why the biggest cost-item (bordering prohibitive) in our regulatory budget is the 60601-1 3rd edition testing??
After 15+ years in the medical device industry I always felt that the regulatory burden is too big to bolster innovation, but the 60601-1 3rd edition is a down-right killer. No sane inventor with ideas for smart high-tech consumer oriented medical devices to better our healthcare outcomes will step in this sector.
Sorry for the long post - you asked for it
