Six ISO 13485 Queries

B

Blue_Adams

I have a few questions. please help.

1. What is the difference between ISO13485:2003 and ISO13485:2012?
2. I don't have a product to launch just yet but I would like my Quality System to be ISO 13485 certified. But will BSI/TUV do that?
3. IS it required to have an auditable Technical File for EU before I can be awarded the certification?
4. I have a pre-certification audit scheduled to get a gap analysis. Is not having a Technical File a deal breaker for ISO certification?
5. Do I need to establish a European Authorized Rep before I can be awarded certification?
6. Can the certification be Quality System specific and not product specific?



We are a medical device company with a Class II device, still in the middle of clinical trials and no commercialized product. So, technically a design/development company.

Looking for guidance from the quality/regulatory gurus out there!

Thanks
 

Ronen E

Problem Solver
Moderator
Hi,

1. There is no such thing as "ISO 13485:2012". You are probably referring to EN ISO 13485:2012, which is the EC harmonised version. If you are going for a CE mark, this would be the applicable standard. Otherwise, the international applicable ISO 13485 version is the plain ISO 13585:2003 one. The differences are minor, as far as practical application and certification are concerned.

2. I don't think there would be any problem with that, especially given that you're working towards commercialization.

3. ISO 13485 may not have the terminology "technical file" in it, but it has provisions that resemble it. If you're not placing a medical device on the EC market, ISO 13485 is not concerned with the EC Medical Devices Directive's requirements (a technical file is one of them).

4. Refer to answer #3 above.

5. No. You have to get an EC Rep only if you don't have a registered place of business in the EC, and you are placing your product on the EC market (i.e., in your case - not yet).

6. An ISO 13485 certificate is always system specific. Products are mentioned at a generic level.

Cheers,
Ronen.
 

DannyK

Trusted Information Resource
I agree with the answers provided by Ronen.
I would like to add a little bit to the question #2 about not having a product to launch.
One of the first questions a CB will ask is for the scope of your system.
Depending on where you sell the device (i.e. Canada) the scope statement could be different.
I believe you should develop a regulatory strategy on where you went to sell the product and tailor your quality system to meet the requirements.
It would be a shame to get ISO 13485:2003 and then find out you need another audit to meet another country's requirements.
If your scope is defined- you must show the CB that you are prepared to meet the requirements. If you did not receive any orders, you still have to demonstrate that the system is ready to accept orders and everyone involved understands the system.

Good luck!

Danny
 
B

Blue_Adams

Thanks Ronen and Danny for the insightful answers. The situation, indeed, is complicated. Some more facts:

1. We are a company of 10 people, the QA/RA team of 1!
2. The regulatory strategy is still being devised. Ultimately we would like to quickly sell everywhere but US launch is the first goal.
3. Launch is not expected until early 2015. That means to me that another audit would be ok as we would be hosting surveillance audits from the NB anyway.
4. The major goal at hand right now is "Get quality System certified to ISO13485"

Based on the above, if you could let me know your thoughts on how to navigate this with the NB and get certified.

A million thanks!
 

Ronen E

Problem Solver
Moderator
Thanks Ronen and Danny for the insightful answers. The situation, indeed, is complicated. Some more facts:

1. We are a company of 10 people, the QA/RA team of 1!
2. The regulatory strategy is still being devised. Ultimately we would like to quickly sell everywhere but US launch is the first goal.
3. Launch is not expected until early 2015. That means to me that another audit would be ok as we would be hosting surveillance audits from the NB anyway.
4. The major goal at hand right now is "Get quality System certified to ISO13485"

Based on the above, if you could let me know your thoughts on how to navigate this with the NB and get certified.

A million thanks!


Hi,

I don't see how the above "complicate" the situation. it's all pretty normal and common for start-up companies. I also don't understand why you place the highest importance on ISO 13485 and NB involvement if your primary goal is the US market. You should be focusing on 21 CFR 820, for which there's no certification. I also recommend that you construct your QMS such that it would be compliant (or fairly simple to adjust to comply) with 13485, for your future moves. Get an experienced 3rd party to audit you - not for certification purposes, but to confirm that you do comply; first and foremost with part 820, and with 13485 as an ancillary.

Cheers,
Ronen.
 

Wes Bucey

Prophet of Profit
I agree with two things:

  1. not much difference in versions of 13485
  2. worry about FDA FIRST (or leave the USA to make your organization HQ)
I might also suggest a market analysis of WHO needs your product, WHAT competitors exist, WHY any customer would buy your product instead of a competitor's, WHEN your product might be ready (pending successful conclusion to trials), HOW you can produce this product at a price point that makes it economically viable, HOW MANY you might be able to sell as your market share, HOW you will advertise and market this product in the various market areas you project, HOW MUCH front end capital you will require before the product is selling and producing a profit, WHETHER you intend to remain the manufacturer or will sell manufacturing and marketing rights to a larger organization.


:topic:
The last paragraph is the essence of the due diligence we used to undertake when I was an investment banker.
 
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