QMS software recommendations for a small ISO 13485 company

#1
HI, everyone, I am new in this forum. I am handling the ISO 13485 compliance for a medical device company. Our company is small but we sell 2000+ products to customers. I am thinking of a cloud-based ISO 13485 compliance software to manage the quality and get the certificate for 13485. Is there any solution suitable for small business?

Thanks.
 
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Imecoli

Starting to get Involved
#2
I have used some pricey ones (documentum) and working on implementing a cheap one right now (Veeva).
Depending on how you want to use it, Veeva isn't the best solution, maybe its their rate of growth but their support promises vs deliverables isn't on par. maybe off the shelf works, but the workflows didn't work for us. our customizations wernt outrageous but getting them to work properly has been an issue. For us I think the locked word docs and a training matrix would've still been better solution for a company ~ 100.
 

Mark Meer

Trusted Information Resource
#3
HI, everyone, I am new in this forum. I am handling the ISO 13485 compliance for a medical device company. Our company is small but we sell 2000+ products to customers. I am thinking of a cloud-based ISO 13485 compliance software to manage the quality and get the certificate for 13485. Is there any solution suitable for small business?
Hi pplcat, welcome to the forum! :bigwave:

Define in advance what your requirements are. For example, perhaps you want:
- Automatic timestamped revision history
- Customizable access permission
- Export/backup of data to generic/portable formats (PDF, CSV,...)
- Need to be able to track specific data (e.g. related to your quality objectives or performance indicators)
- ...

Also, depending on your needs, don't discount what free resources are available before rushing out and purchasing a software package.

Google Drive, for example, is a very powerful tool, as it maintains automatic revision history, and the access controls can be customized.

I'd say that a lot of what you pay for is "look-and-feel". If it's not important that your records be nicely formatted, with company header, etc., then simpler solutions are game. Simple spreadsheets and templated word-docs will often suffice in a lot of cases. As long as the required data is there, and everything is legible.

Finally, you probably want something that has a lot of flexibility (potential customization). The problem with a lot of pre-packaged ISO software is that they define in advance your business needs, instead of the other way around. You need to be able to tailor the software to YOUR requirements. In this respect, we've had good experiences with wiki systems, as they make linking documents/records/references a breeze. Takes some time to setup (as far as I know there are no out-of-the-box ISO 13485 wikis), but worth it once established.

Best of luck!
MM.
 

QuinnM

Starting to get Involved
#4
Hi pplcat,

I have implemented a cloud based software system for a small medical device company under 13485. The system you select will need to be validated by you or your company. Some systems have no validation, while others have the IQ and OQ done and your company completes the PQ. You could obtain a great package that costs 25K+/year, but for us that was out of our budget. We have about 15 employees, and I selected Verse solutions from ETQ. I do not work or own stock in ETQ, and the system is not perfect, but has an excellent balance between options and cost. I would also recommend cloud-based software. One last point to consider, obtaining a 13485 cert is not based on having QMS software. If you have something in place now, you could obtain the 13485 cert without the software system.

Quinn
:2cents:
 
#5
Hi pplcat,
As a small company providing Software as a Medical Device (SaMD), we support our clients who manufacture and commercialise Class IIb medical devices (primarily) and therefore we have to show that our software development process ticks all the right boxes. To do this, we have to demonstrate that we have a QMS equipped to consistently meet customer requirements and regulatory mandates in the context of the field of medical devices. It has been recommended to us by one of our clients (a leading MD manufacturer) that we use Confluence and Jira as main tools to manage and document internal processes. From our personal experience as a small dev team, initial update and integration were a tiny bit painful, however, adopting the use of both tools has proven to be highly beneficial and a good investment indeed. These tools add a whole new layer of value in making things more auditable and transparent and enhancing communication. It is one of our unique selling points now when we talk to potential clients, especially since we are in this heavily regulated and risk-averse space.
Unfortunately, I don't know the full pricing information and details, I think we are still trialling the free versions but I can ask and let you know?
And again, as somebody above me mentioned, it would depend on what your requirements are so it would be advisable to define these first.
Hope this helps and good luck with your decision making!

p.s. Confluence is unparalleled in creating decision-making logs and document version tracking among many other features. Jira is perhaps slightly more relevant for software dev teams as it enables the creation and tracking of issues during sprints.
 
Last edited:
#6
I recommend Q-Pulse does that fall within your budget?

It's user friendly and the support is very good although it's not cheap.
 
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