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UL Listings & other certifications...

UL Listings & other certifications...

UL Listings & other certifications...

(OP)
I recently started a company working with another engineer & an anesthesiologist. Basically we are developing new medical devices. I have some questions concerning UL listings and the like.

For our first projects, we chose more simple devices which wouldn't require any certifications etc., but now that the ball is rolling we are considering some more in-depth projects. Basically, I'm curious what we need to do other than UL listings, etc. Neither I nor my EE partner have our "PEs" yet, so I know that is going to cause some headaches. Can someone give me a rundown of problems we could run into? Anything we will tackle in the near future will be relatively simple. Small, microcontroller based devices, etc.. I know UL listings are expensive, and take some time, what are the other pros & cons? Are there any other listings/certifications we need, or that would be benificial? Obviously since we will be designing devices which will be used in the Medical field, liablility is a big concern. How can we protect ourselves in that area?

Thanks for any help!

RE: UL Listings & other certifications...

Hi,
     EESteve,
      For any design to be accepted, first of all you have to ensure in which country you are going.  Above all IEC is accepted globally. Also MIL (military) standards are also required in some application. As you deal with medicals i suppose you may have to think about MIL also.  these details you can find out in www.ieee.org.
Regards

 

RE: UL Listings & other certifications...

UL is strictly for the U.S. market.  Other countries will have equivalent testing requirements.

I'd suggest you contact UL directly.  They should be happy to give you the background information you need.  

I suspect that developing a testing procedure for a new medical product will be quite expensive.

RE: UL Listings & other certifications...

Hi, the best way to avoid liability is to sell outside the US. Lots of cash can be made selling in the third world where price is often the most important feature.Just remember to get the cash first!

RE: UL Listings & other certifications...

First I would avoid getting a "PE".  That just opens you up to personal liability, even if you  are hiding behind a corporate shield.
If you want to sell "medical" devices in the U.S. or Canada, you will need to have an FDA certification for the equipment.  Part of this is an extensive paper trail as to how the design developed, were proper design reviews held before each design change was made, were test reports completed at each phase, etc., etc., etc.
Then, depending what you are doing there is also AAMI certification.
And of course, last but not least is the pain-in-the-butt UL.  These guys will do anything to make you spend more money with them.  Even to the point of violating other national standards.
The easier way to do all this, is to develop a great product, get someone to buy you, and let them get the certifications.  Then start a new company and do it all over again.  You can end up with a lot more money this way.

RE: UL Listings & other certifications...

My UL experience is with industrial controls but we did design something for use in the dental field. This is likely quite a bit different than medical. Just call up UL and they will direct you to someone that specializes in your area. They can be quite informative if you talk to the right people and not a newbie. If your selling outside of the US, as well or plan too, to a country that has a safety or similar mark then go with a company that can multiple mark the product which could save you thousands of dollars (not too much though because UL still has to sign off on the test so they still get some money from the other test houses that are UL marking a product). UL is working towards documenting the differences between IEC and their own standards (at least for UL508 and UL508A) although they have not released any info yet. UL and CSA can also test to the others standards if you let them know right away, potentially saving money.

RE: UL Listings & other certifications...

EESTEVE

UL,(USA Certification) FCC, (USA Certification) and CE
(Euro Certifications) are cheap and easy to get.

There is a company in Orlando, Fl. called "Interteck"
They do the certifications. They will even do Euro-certifications, if requested. These certification companies
are all around the USA. They are privately ran.

Since you are dealing in the medical field, you may need
additional certifications.

RE: UL Listings & other certifications...

In my experience (with UL and CE), neither are cheap and neither are painless if you haven't designed an industrial product with these standards in mind. I have always heard that medical standards are even more stringent due to the application so these are probably even more expensive. Of course, the complexity of the product and the actual application can change the cost one way or the other. Good luck.

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