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Contracted Manufacture Company wanting to be able to design and manufacture own product.

love02eat

Involved In Discussions
#1
We are a contracted manufacturing company we design nothing. We make medical tubing to customer drawings only. The company is wanting to possibly design there own custom medical tubing and become the end user. The question has come up wanting to know what steps would have to be taken when it comes to regulation can we stay just certified to ISO 13485:2016 and will this open the door to be audit by FDA and what other regulators would the company be subjected to. Any guidance would greatly be appreciated.
 
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shimonv

Trusted Information Resource
#2
As a manufacturer of a medical device you can stay "just certified to ISO 13485:2016" but once you become a legal manufacturer you will need to follow all the applicable regulations, e.g. submission, registration, listing, adverse event report, UDI, and be subject for inspections.
That's the short answer :)
 

Tagin

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#3
You may be currently excluding Design & Development from your ISO 13485 certification, since you don't do design. But if you start doing D&D that would have to change.
 

love02eat

Involved In Discussions
#4
As a manufacturer of a medical device you can stay "just certified to ISO 13485:2016" but once you become a legal manufacturer you will need to follow all the applicable regulations, e.g. submission, registration, listing, adverse event report, UDI, and be subject for inspections.
That's the short answer :)
Yes the company would like to get into D & D. so we would no longer be excluded from section 7.3 with that would we lean on our Registrar or Notified Body rep to help us make this transition if not what type of company would I lean towards getting quotes from?
 

shimonv

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#5
You'll to hire a QA/RA experts or get help from a consultant. The registrar / notified body do not provide such services.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Yes the company would like to get into D & D. so we would no longer be excluded from section 7.3 with that would we lean on our Registrar or Notified Body rep to help us make this transition if not what type of company would I lean towards getting quotes from?
"Getting into D&D" is not a small thing but it's not the only thing you'll have to do. You'll probably have a lot more regulatory obligations to cover (as Shimon hinted). In that context the first thing you'll need to figure out is what markets/jurisdictions you're going to target. This will point to what regulatory systems you'll need to comply with and which bodies will audit/inspect your operations.
I'd be happy to guide you through such transition - I have design, manufacturing, QA and regulatory experience related to IV catheters and other IV tubing / accessories. Please send me a private message if you'd like to start a discussion.
Thanks,
Ronen.
 

Watchcat

Trusted Information Resource
#8
become the end user.
I am also puzzled by this. You are planning to design custom medical tubing for your own use? Something seems to be amiss here. The end users of medical products are healthcare professionals and patients. Do you mean you want to label it as your own product and sell it yourself? That doesn't make you an end user. That makes you a legal manufacturer.

we stay just certified to ISO 13485:2016 and will this open the door to be audit by FDA and what other regulators would the company be subjected to.
The regulators you are subject to are determined by the jurisdictions in which you sell your tubing.

The specific regulations that will apply to your product in each jurisdiction are determined by whether your product meets the definition of a medical device and its regulatory classification in each jurisdiction.

If you plan to sell your product in the US, and it meets FDA's definition of a medical device, you will have to register your facility and the device with FDA. That is what will "open the door" to an FDA inspection. You will also have to comply with FDA regulations, including the Quality System Regulation, which is similar, but not identical to, ISO 13485. FDA does not recognize ISO 13485.

In the EU, you may need a notified body to certify your device. If you don't already have one, you will not be able to get one this year, and maybe never.
 
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