Recommend Registrar for a Small Company - ISO13485

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mr.mike

Well Met Everyone!

I was just going through the thread on registrar recommendations, but I'm unsure if I (my company) can relate or not.

The fact is, we are a VERY small (5 people) medical device company, developing only low-to-medium (Class I & II) devices.

As such, I think our criteria may be slightly different from many of you big-players, and I was hoping we could narrow the recommendations based on the above.

Basically, here's what we would be looking for (pretty much in order of priority):
1) Approved by Health Canada (we are from Canada). Their list, however, includes the usual big names: BSI, SGS, QMI, TUV America, TUV Rheinland, Intertek, KEMA, Loyd's, NSAI...
2) 13485, IEC 60601-1 (CB test-report), notified body services
3) Reasonably priced (...did I mention we are a tiny company :eek:)
4) Based in North America (not critical, just for logistics)

So, if anyone has any recommendations based on these criteria, it would be greatly appreciated.

Thanks in advance,
MM.
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
Re: Recommend registrar for a small company?

I haven't used any Registrar for Medical, only AS9100 and ISO9001 so I can't help you here. But as for the costs, I think they are based upon number of employees unless that has changed. You may have to deal with the bigger Registrars because they are approved in Canada. I think DnV is part of the group you listed and you have BSI. Now from an AS9100 or ISO9001, either BSI, NQA, ASR (ISO9001 I am not sure if they have accreditation for 13485) or DnV only because I have worked with those Registrars, and they fit the need of the Organization. But, this is my opinion.

You need to take into consideration, which Registrar will meet your need and the company's needs.
 
D

db

Re: Recommend registrar for a small company-ISO13485?

I have several small companies I work with that are 13485. They are all below 30 employees. A couple of registrars I know that seem to work well with small companies are NSF-ISR ( out of Ann Arbor, MI) and Eagle Registrations (out of the Dayton, OH area).
 

Wes Bucey

Prophet of Profit
Re: Recommend registrar for a small company-ISO13485?

I haven't used any Registrar for Medical, only AS9100 and ISO9001 so I can't help you here. But as for the costs, I think they are based upon number of employees unless that has changed. You may have to deal with the bigger Registrars because they are approved in Canada. I think DnV is part of the group you listed and you have BSI. Now from an AS9100 or ISO9001, either BSI, NQA, ASR (ISO9001 I am not sure if they have accreditation for 13485) or DnV only because I have worked with those Registrars, and they fit the need of the Organization. But, this is my opinion.

You need to take into consideration, which Registrar will meet your need and the company's needs.

I have several small companies I work with that are 13485. They are all below 30 employees. A couple of registrars I know that seem to work well with small companies are NSF-ISR ( out of Ann Arbor, MI) and Eagle Registrations (out of the Dayton, OH area).
The deal with ISO 13485 registrations is hinged on the "harmonization" aspect. A company has to ensure the registrar it selects is on the approved list of the countries (just the major ones) where it expects to sell products. USA, of course, doesn't yet buy into the harmonization aspect, so companies have to have BOTH FDA and ISO registration if they expect to do business in USA.

The approved lists change, so it is wise to confirm with any registrar you interview that it is qualified by the major countries where you expect to sell product.

Obviously, there is a difference in price between registrars, but price should not be your only criterion.
 
M

MIREGMGR

Re: Recommend registrar for a small company - ISO13485?

If you may be interested in participating in US FDA's upcoming Voluntary Audit Report Submission Program, you will want to verify that your registrar is appropriately accredited by the supervisory authority in Japan, Australia, Canada or the EU. It appears per the current guidance that a US-only registrar's audit report would not be eligible for acceptance, notwithstanding the validity of their ISO 13485:2003 certificate.

I don't know of your customers, of course, but my employer has been told directly by various customers that they favorably regard our having chosen a registrar with a substantial international reputation to uphold.
 

DannyK

Trusted Information Resource
Re: Recommend registrar for a small company - ISO13485?

Well Met Everyone!


Basically, here's what we would be looking for (pretty much in order of priority):
1) Approved by Health Canada (we are from Canada). Their list, however, includes the usual big names: BSI, SGS, QMI, TUV America, TUV Rheinland, Intertek, KEMA, Loyd's, NSAI...
2) 13485, IEC 60601-1 (CB test-report), notified body services
3) Reasonably priced (...did I mention we are a tiny company :eek:)
4) Based in North America (not critical, just for logistics)

\MM.

You can only select the CB that have been approved by Health Canada in order to get CMDCAS approval and sell in Canada.

If you want to get CE marking then you need a CB who is a notified body and based in Europe.

It may be useful to get an independent lab to perform testing to IEC 60601-1 since they may be closer and more responsive to your needs. There are several labs in Canada that provide better service than the certification body.

There is not much lee-way in terms of pricing. One factor that can reduce your costs is having a local auditor which can cut done on travel and hotel costs. Pricing also depends on the complexity and classification of the device.
The best way is to find out which registrar has a local presence.

I perform ISO 13485, CMDCAS, CE marking audits on behalf of a CB and audit small companies with less than 10 employees quite frequently. The CB account or sales managers should be able to walk you through the process and outline all the costs involved.

One other criteria that you may want to add is "Time to market". I have heard horror stories of companies having to wait many months for a certificate due to the CB bureaucracy.
 
M

mr.mike

Re: Recommend registrar for a small company - ISO13485?

Thanks for your replies everyone.

db, unfortunately neither company you mentioned is on the list of registrars approved by Health Canada, and this inclusion, for us, is paramount.

As for everyone else, thank you for the advice. As it is, I guess we'll just proceed on course. That is, contact and question all possibilities.

I was hoping that there were certain registrars who had more of a reputation for dealing with small companies, but by the sound of it, a large, well established one (UL, SGS, NSAI...) might be the way to go...

MM.
 
M

mr.mike

Re: Recommend registrar for a small company - ISO13485?

Hi DannyK,

Just want to clarify one of your points:
If you want to get CE marking then you need a CB who is a notified body and based in Europe.

Most of the larger CBs have outlets all over the world, so when you say "based in Europe", does that mean the HQ has to be in Europe?

Also, on a slightly related note, as far as I gather the Australian TGA requires a "sponsor" to act as an intermediary between non-Australian companies and the TGA. This sponsor must be Australian. So, does this mean we have to source out yet another organization from Australia, or can some of the international registrars act as such a sponsor, assuming they have outlets in Australia.

Thanks in advance,
MM.
 
M

MIREGMGR

Re: Recommend registrar for a small company - ISO13485?

It's not of the nature of a recommendation since I'm sure others are equally good, but we're happy with our BSI relationship.

They have a US base; they're CMDCAS; they're suitably authoritative in Europe; they need us less than we need them so they're not shy about calling a spade a spade when appropriate, so we get our money's worth in regard to improvements; and as I noted above their reputation and size satisfies those of our multinational customers that have rigorousness-expectations with respect to how we handle quality/regulatory matters.
 
M

MIREGMGR

Re: Recommend registrar for a small company - ISO13485?

the Australian TGA requires a "sponsor" to act as an intermediary between non-Australian companies and the TGA. This sponsor must be Australian.

If your company doesn't have an Australian sales/distribution office, the sponsor is your Australian master distributor.

It's common for (what I call second-tier) national regulatory systems to require a national master distributor to agree to be responsible for imported products. Korea FDA, China FDA and many other national systems work that way.

If the national regulatory authority detects a problem and wants to nail somebody, it would be expensive and difficult for them to take quick and effective action against a US, Canadian or European company. The national master distributor on the other hand is readily available for instant regulatory action as needed.

Your ISO13485 registrar is not part of your direct regulatory-conformance effort in a second-tier country, other than in regard to the certificate they issued you.
 
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