Developing a QMS for biomedical start up company which only does R&D?

O

Osteoang

#1
Hello.
I am developing a QMS for biomedical start up company. We only do R&D, in that we will not be supplying a product or a service, merely licensing the technology for use in medical device companies (our technology is surface modification for orthopaedic devices). Our customers will handle all the validations and necessary approvals. Has anyone else in this forum experienced this type of scope for ISO 13485?
Thank you
 
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R

Roland Cooke

#2
Hello.
I am developing a QMS for biomedical start up company. We only do R&D, in that we will not be supplying a product or a service, merely licensing the technology for use in medical device companies (our technology is surface modification for orthopaedic devices). Our customers will handle all the validations and necessary approvals. Has anyone else in this forum experienced this type of scope for ISO 13485?
Thank you
Very informally, I consider there to be distinct differences between Research, Design, and Development, and have worked with companies that do all three, or only one of the three. Essentially I think of the three like this:

Research - looking for ideas
Design - turning ideas into marketable products
Development - adapting/converting/enhancing existing products

I don't really see a problem in your company holding ISO13485 for this kind of service application.
 
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I

icare2much

#3
If I understand, you've done the Research and Design portion already, and now have specifications developed. And now you wish to license the use of the technology, of utilizing your specifications to affect the surface modification.

I would guess that what you have created is similar to a component specification, not a finished medical device.

ISO 13485 is geared toward regulatory compliance - which does not directly apply to you. I think you could use it, but you will have interesting exclusions, and the safety risk portion could be tricky if your design is already finished and safety risks were not considered throughout the process. Perhaps other Covers can provide real life examples.
 
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O

Osteoang

#4
Thanks to both the previous posts for replying to my question. This is helpful for me as I am on a learning curve. I will be clarifying over the next few weeks as to which exclusions will apply, but yes - I do expect that they will be interesting.
Thanks for clarifying the three different categories for design, I am currently writing the R&D, design procedures so this is a big help.
 
R

Roland Cooke

#5
I think 13485 is probably okay for this kind of research, but you should definitely define your argument.

Essentially, if I understand things correctly, your end product is a surface modification technology that will be sold to an orthopaedic company. That orthopaedic company can then apply that technology to create new variant marketable medical devices.

In order for your customer to get regulatory approval for these products, they will need to demonstrate that the new coating is safe and effective. Some of that S&E evidence is likely to come from your research efforts.

So it will be useful to be able to show that the original research was conducted in a controlled manner; the control being gained via a robust QMS.
 
O

Osteoang

#6
Hi Marc
Thanks for your advice. We are separating out our pure research from our development work, but both will be controlled. Of course the development work will be controlled along the lines of ISO as this will be covered by our scope, but we will make sure that research side has controls also.
Thank-you
 
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