ISO 13485 consultants and auditors with design oriented focus

[mbellisle]

Hi all,

I work at a small company that designs medical devices for various customer and we do not participate in manufacturing. Specifically, we develop the device up to prototype and then transfer everything to the customer.

We are working towards getting ISO 13485 certified and have had a number of external audits (pre-audit, customer audits). We have received varying feedback depending on if the auditor was manufacturing or design oriented. We ended up getting dinged on more areas with the auditor that had manufacturer experience. Our current goal is to find a consultant that has more design experience rather than manufacturing so we can focus our efforts in the correct areas.

Are there any recommendation for consultants and/or advice on how to find one? We are hoping to find someone who is in the New England area.

Thank you!

 

[Hi_Its_Matt]

Are you looking for someone to more-or-less one-time audit your organization, and identify deficiencies/nonconformities? Or to help you prioritize the findings you have already been issued? Or are you looking for more of a full-time, or mostly-full-time consultant to help you work towards certification?

 

[mbellisle]

We are looking for someone to audit what we currently have in place and then potentially continue working with us as we work toward certification

 

[Ronen E]

I live and work in Australia, but happy to help you remotely. From experience, quite a lot can be achieved this way. Typically the more significant difficulties in remote auditing/consultation are related to physical production, but it sounds like this is only a relatively small part of your operations.

Actually, it would be lovely to visit New England in fall... The colours...

 

[mbellisle]

I live and work in Australia, but happy to help you remotely. From experience, quite a lot can be achieved this way. Typically the more significant difficulties in remote auditing/consultation are related to physical production, but it sounds like this is only a relatively small part of your operations.

Actually, it would be lovely to visit New England in fall... The colours...

Hi Ronan,

Thanks for the response! What kind of experience do you have?

Additionally, I wanted to give some more information:

Our hope is to find a consultant that has an understanding of small design firms and is pragmatic about a narrowing the scope of the quality system.

We have solid design and development procedures in place but need to improve/create the supporting QMS procedures that are applicable to us. We only deal with medical devices at the prototyping stage and then transfer the entire design to our customer. From our understanding, since we are not the end-product manufacturer, there are some aspects of ISO 13485 that we are not responsible for.

As a small company, we want to ensure that we are focusing our efforts in an efficient manner rather than over-embellish. The company has been around for over 30 years so we have existing "procedures" that, before this year, were not documented to the level of ISO 13485. There are still some gaps that need to be addressed so the goal is to expand on our existing structure and ideally, reduce the number of drastic changes.

 

[Ronen E]

What kind of experience do you have?

On the left hand side of this page, if you click on a user name under their avatar (mine, for instance ), and then scroll below the header section in the user's page, you'll see a blue ribbon showing "About" as the last item on it. This will take you to the details the user provided about themselves. In my case, the top item ("Website") is a link to my LinkedIn page, where you can see some information about my experience.

If you scroll a little down on the About page, you'll see a Contact section. In my case my direct email and phone number are there - please feel welcome to contact me. You are also welcome to send a PM here or in LI.

Cheers,
Ronen

PS Yours sounds to me like a fun little straightforward project I know, I know, nothing in life is straightforward...

 

[I_Moy]

Hi @mbellisle , I'm also happy to help with pre-audit prep and remediation. I work with a number of startups who are doing their own design but contracting out manufacturing and I set up their quality systems with only what they really require. You can find me on linkedin (Ide Moynihan or Moynihan Quality Consulting). Please feel free to reach out for a call to chat about your needs or reply here with any specific questions and I'd be happy to help. Unfortunately not based in New England but I do most of my work remote anyway.


kind regards
Ide

 

[Parul Chansoria]

Hi,

Thank you for your post here. As per your requirement, I shall be pleased to support you. I do have a lot of design experience, and have built a strategy around the construction of a Design History File (DHF), developed plans for DHF creation and remediation, and supported and guided through effective implementation of the product realization clause of ISO 13485 and design controls.

All these efforts helped the company in getting its ISO 13485 certification. The company I helped was a specification developer. Similar things applied to some legal manufacturers that outsourced the manufacturing work but focussed on design.