QMS Development Question- Small Medical Device Manufacturer

SJB1095

Registered
Hi there! We are a small (three employees!) medical device manufacturer of a class 2, 510k waived medical device (device #1). We have a QMS system that has passed FDA audit (whew!) to support this device and its distribution. We may be soon registering a new device (device #2) that is not 510k waived with the FDA, so we need to develop an additional QMS system for this device.

Whilst building out the QMS system for device #2, we'd like to improve the current QMS system for device #1 (it's "good enough" but the FDA audit did highlight some gaps in our understanding of the system and we think we'd benefit from a professional to come in and make it more cohesive). We don't just want to duplicate the current QMS documentation for the new device if we believe it could be better.

As a very small team, we do not have the bandwidth or the knowledge to improve the system for device #1 and build out the system for device #2. Now comes my question-- in your experience, what is the best source to assist us with this task? We are more focused on someone to come in and work almost exclusively on creating/ improving documentation for the system versus consulting/ training on system adherence. Should we engage a consultant? A company? Software? Purchase a template? Any cost insight would also be beneficial if you are comfortable sharing.

Doesn't have to be a specific recommendation, any direction or advice would be so helpful! Thank you in advance-- it is much appreciated!
 

shimonv

Trusted Information Resource
In my opinion -it is time to hire a full time employee to upgrade and maintain one QMS for both devices. Their'll be plenty of work for him/her. And if you can't find the right person start with a consultant while you continue with your search.

Good luck,
Shimon
 
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Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Since your regulatory burden is getting bigger and not smaller I agree with Shimonov. The FDA submission itself will be a huge project (depending on claims)

This is what they call the barrier to entry to a market. For Med devices the regulatory and quality burden are gigantic. You need dedicated employee (s). The bad news is its $$. Ther good news is its tough for a copycat to come along.
 

yodon

Leader
Super Moderator
Recognize that quality and regulatory are separate but linked disciplines. Hiring someone for supporting your quality system may not cover all those bases so take that into consideration.

I'm more in the get a consultant first camp. Get the foundation set and operate for a while to see if it makes sense to hire someone full time.

I do NOT recommend going the purchase a template route. That's likely just to confuse matters.
 

davishont02

Starting to get Involved
I am going to " Yes and" all the people that commented before me. And add since you have a gap in understanding that has been identified during your contact with the FDA, you want to bring in experience - whether that comes in a full-time QMS Manager or a consultant. If cost is a barrier in addition to size, depending on your knowledge, if you go the consultant route you can very well ask for a gap assessment and quality plan to improve your QMS to accommodate your new product and classification requirements; then execute the plan yourself. Hourly costs for consultants could balloon when overhauling a QMS, so it may be beneficial to negotiate a project rate or bring in a fractional consultant set to a retainer and a monthly hourly bucket of hours.

Also, if you are going to invest in improving your QMS, don't forget to consider any product expansions into new markets/countries within into the next 2 years. This would increase your consideration beyond just the FDA regulations., you would have to consider having a QMS with procedures that could support applicable regulations and standards across countries.

Happy Hunting!
 

Ronen E

Problem Solver
Moderator
This would increase your consideration beyond just the FDA regulations., you would have to consider having a QMS with procedures that could support applicable regulations and standards across countries.
...and possibly exponentially increase your costs :lmao:
EU MDR is a monster, and quite different from FDA requirements (not in essence, but it will bring in a lot of extra work). I would NOT include it in the scope of a budding system which is more naturally FDA-oriented. In theory it's more efficient and "wiser", but in practice it could cause the whole structure to go sideways.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
...and possibly exponentially increase your costs :lmao:
EU MDR is a monster, and quite different from FDA requirements (not in essence, but it will bring in a lot of extra work). I would NOT include it in the scope of a budding system which is more naturally FDA-oriented. In theory it's more efficient and "wiser", but in practice it could cause the whole structure to go sideways.
Macron recently commented that the EU is over regulated and losing business. I tend to agree. MDR feels much harsher than mdd. I thought MDR would just require a few new tests and documentation. Ha. I was wrong.
 

Ronen E

Problem Solver
Moderator
Macron recently commented that the EU is over regulated and losing business. I tend to agree. MDR feels much harsher than mdd. I thought MDR would just require a few new tests and documentation. Ha. I was wrong.
This is nothing new. Macron is simply repeating many others before him.

I don't know how closely you followed the evolution of the MDR from the PIP scandal days up to its release in 2017, but it was expressly intended to be "harsher" than the MDD. It was concluded back then that the MDD was not up to scratch anymore and the game needed to be lifted (which I tended to agree with at the time). The problem is that they overdid it. Erik Vollebregt covered it very nicely, in great detail and from many different aspects in his blog, over the years. Highly recommended.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Thanks. I agree they went in the right direction but I think for current products with a proven track record the delta should be less. Safe and effective products could be taken from eu patients because the manufacturer doesn’t want to invest more money into product development
 
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