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Rich Quinnell

Live Chat – Friday, February 20 – MCUs in Medical Design

Rich Quinnell
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Rich Quinnell
Rich Quinnell
2/27/2013 7:29:04 PM
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Certification cost
I don't know how much it costs to certify a product, and it probably depends on how complex the product is and its interaction with the patient. When I was working on a surgical laser design many years ago, we had a staff whose function was solely to shepherd designs through the certification process. It involved both a lot of testing and a lot of documentation of the design.

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Rich Quinnell
Rich Quinnell
2/27/2013 7:23:25 PM
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Re: MCUs in healthcare
Regulations vary by country and so the question of what cost is involved is hard to answer. In the US the FDA controls whether or not a device can be released for medical care, and they require considerable testing and documentation, and require re-certification if changes get made in the design or software. The FDA has requirements both on function and safety, requiring that there be a proven theraputic value to obtain certification. Things may not be as highly regulated elsewhere, but I don't really know.

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David Maciel - UDTEC
David Maciel - UDTEC
2/27/2013 2:49:34 PM
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Program Manager
Internal Ac-Dc Medical Power Supplies
CUI has developed a line of medical power supplies that offer class leading power density and energy efficiency. Carrying 60601-1 medical safety approvals, these power supplies excel at delivering power in an extremely compact package, making them ideal for diagnostic, home healthcare, and dental applications where space is limited and minimizing energy consumption is a priority.

More informations :

http://www.cui.com/Catalog/Resource/1328

 

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jkvasan
jkvasan
2/27/2013 9:37:02 AM
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Re: Ratification
The charges were somewhat similar. If you could write to them, they normally reply with the exact quote. They are a very professional organisation and co-operate very nicely.

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ASEEMOV
ASEEMOV
2/27/2013 9:16:57 AM
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Program Manager
Re: Ratification
Thanks, that's good to know. These guys used to do only pre-certification earlier and provide feedback. So, looks like they have upgraded. So, the charges you mentioned in your previous post were from SAMEER (I assume so because you back converted from INR to USD :-))?

 

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jkvasan
jkvasan
2/27/2013 8:53:47 AM
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Re: Ratification
Aseemov,

EMI/EMC certification is done by SAMEER, a central government organisation, which is in both Mumbai and Chennai. Their staff are very meticulous and do a great job.

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ASEEMOV
ASEEMOV
2/27/2013 8:28:51 AM
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Program Manager
Re: Ratification
jkvasan, Do you know of any test labs in India which are authorized to give the certificates (EMI/EMC)? I knew a few in Bangalore which did only evaluation (that was about 8 years back)- they were good to get feedback on your product but none authorized to provide any certificates. This had to be done in eastern coutries. How is the scene today?

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Rich Quinnell
Rich Quinnell
2/26/2013 3:59:40 PM
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Re: Best wishes
Thanks. Doing pretty well, considering they ripped my chest open and replumbed my heart. Will be headed home soon (currently trapped in Phoenix awaiting medical clearance to travel.)

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David Maciel - UDTEC
David Maciel - UDTEC
2/26/2013 9:16:16 AM
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Program Manager
Re: Ratification
It's a good technique, anyway unfortunately we need some time to recover the amounts invested in a product, with the caveat that it is not a release where we can put the profit margin far greater than the possible.

And so ends up working, I remember a little electronics launched both a Bluray player, opened the market to a value of around $ 300.00 about today is the same device at around $ 75.00.

I believe that the volume of sales made to recover all invested. Rsrsrs

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jkvasan
jkvasan
2/26/2013 8:58:04 AM
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Re: Ratification
David, As you said, one needs to face competitors in the real world and due to pricing pressure getting returns on the investment on certification takes a longer time. We use something called a Gate process. The product development life cycle is divided into several gates - gate 0, gate 1 and so on. g0 is where the marketing department is fully involved. Opportunity identification, market analysis, voice of customer, etc are done. Then marketing department would come up withwith the strategy of a projected annual volume and the features needed to achieve this volume apart from target pricing. G1 starts with design department analysing these data and come up with the feasibility study. This way the pricing is more or less decided at the start and some of these bottlenecks are somewhat ironed out.

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