New to Medical Device QMS and would like advice

I recently got promoted from being a Technical Support Specialist to being the one and only person in my company to handle our Quality Management System including the regulatory side of our product design and development. I have no background, no training, just been learning from our QMS consultant and the internet. To top things off I have a prototype medical device that I need to figure out the regulatory side of as we likely will need to submit at least an abbreviated 510(k) if not a traditional. And there is no documentation that was followed for the prototype so I have to figure out what is required and fill in our gaps. Our prototype device is non-contact, non-invasive.

Does anyone have recommendations for resources of information? Our QMS system was just overhauled by a consultant and at this point is at the bare minimum so I don't have a lot of SOP's or work instructions to help me out. I've found the FDA Guidance on 510(k) filing but that doesn't always help with filling out the individual document such as the input-output traceability matrix. I feel quite a bit in over my head, and would appreciate any guidance or resources. We are mainly dealing with FDA regulations currently but we are looking at getting an ISO 13485 certification in the next year.
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Super Moderator
No disrespect, but you're saying you've been tasked with something which you don't possess the competence to do that could effect the effectiveness of your management system as well as product conformity, regulatory compliance and customer satisfaction?

I would not venture where to tell you to start at this point because there is no "best" or "quick" anything in this, and the necessary "competencies" required can't be done overnight, in a few days or even a month and a training course or multiple courses are not the answer at this point. Your leaderships decision to do this demonstrate a level of "dumb" I haven't seen in a bit.

What is your background and why you?
It is actually quite common with medical device startups to have individuals thrust into a role in which they have no background or experience.

Design Control Guidance For Medical Device Manufacturers: Guidance for Industry: Link
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices Link

Read other relevant guidance documents from FDA, GHTF, IMDRF.

Read the standards (ISO 13485, ISO 14971, etc.).

Reach out to this board and read previous threads. Keep in mind that the really old ones may be providing outdated advice.
@Randy I do realize it's not a great position for our company to be in but it is where we are at. I would like to do the best I can and I realize I can not learn this all in a few days or a month, or even a year, it'll be a process. Anything I can do to help that process is appreciated as I do not even know what I don't know. I was a medical assistant prior to becoming tech support for this company. I got promoted because I am intelligent, resourceful, and can learn quickly and frankly we can't afford to hire an experienced person. Our QMS system has already been built by a consultant so I am not starting from nothing, but it is rather bare bones and the processes for design and development are lacking.

@indubioush Thank you for the links, I will read up on those and continue to browse the forum. I was quite happy to stumble upon this forum the other day as it seems like a good resource.


Quite Involved in Discussions
Steep learning curve ahead. All advice above is great. My quick take. Outsource (get a consultant) to do the 510k. Experience matters when putting that together and putting together a sub-par submission with multiple rework loops is not beneficial. FDA has resources (CDRH Learn really is great! Thank you to QuinnM) but learning through trial and error on a 510k is not a good plan. A competent Regulatory Affairs consultant will get your org to market clearance quicker and to revenue quicker. You need, IMHO, is to focus on QMS mastery (fill known gaps) and focus on those elements of most interest to third parties. Complaints, MDR / Incident Reporting, CAPA, Production and Process Control is a good short list to start. Have fun; enjoy the ride!
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Involved In Discussions
I can only echo the above advice. I started as ops manager (which so far has meant mostly QA manager with other stuff thrown in) in May. I had minimal experience but luckily didn't face nearly the obstacle you are facing. I didn't have to worry about a 510k or getting our product to market but I did have to take a very dysfunctional QMS and bring it into control and compliance and lead everyone else along the way. I have learned a ton on this forum and I have been more recently using CDRH Learn as well. Besides that I have just surprised myself continuously both with all of the stuff I knew but didn't know I did as well as how much I was capable of figuring out for myself. Hang in there, and best of luck!!


Involved In Discussions
I admire your willingness to learn and do what you can but calling your tasks a steep learning curve is a huge understatement. People build careers around helping companies be ISO 13485 compliant for specific portions of the standard. I have been at multiple start ups now and I have never been with nor heard of a company doing everything you mentioned with less than 5 people in the quality team. At more established companies, you will often have almost a 1:1 ratio of development team to quality team.

My 2 advice are:
1. Be ready to redo what you already completed multiple times. You will soon find that decisions in 1 part of your QMS have big implications in different portions of your QMS.

2. Be mindful of what you are signing off on. You could get into serious trouble for signing off on things that you don't fully understand.

Sec. 820.25 Personnel.

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
I suggest you talk to management and add to your budget a consultant firm to perform a top to bottom audit of your QMS and related processes.

Request the audit agenda a full month or two in advance. Conduct mock audits internally using that agenda. Make sure you have a table that cross-references requirements from ISO 13485--> FDA QSR--> to your QMS Expect the consultants to find a lot of things wrong. Show the results to management. Hold Management Reviews or management meetings multiple times prior to the ISO 13485 audit.

As Echo mentions ISO 13485 has requirements that management shall "Basically not allow you to claim time, resources, money, education or space" for failure to meet any of the requirements.

To ask a novice like you to take this "beating" should command a high salary. If you are making less than Substantial or much above what you were making prior in Tech support that's an issue for me personally. That's just my opinion. If they refuse to pay you fairly, go ahead and bust ass to pass any submissions or audits and then request a pay raise commensurate with your responsibilities. If you did most of the work alone that is a resume seller right away, in any case.

Also, the FBI trains FDA auditors on interrogation techniques. Technically they are officers of the Federal Government. Sitting for an audit with the FDA and even iso 13485 requires you to be 100% present physically and mentally. You can't be looking for records or documents; you need help with that. Some auditors like to ask detailed questions on other topics while you are looking for something. Don't be the gopher in that case. You need to stay on top of each question and provide the right response and escort the auditor at all times.

Again, have an outside firm audit you and then gather senior management together and as they say, present the good bad, and ugly to them. If you need assistance then is time to present it. Be specific about what assistance you need and when and for how long. I suspect if you try to do this alone you will suffer or quit.

Best of luck
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Involved In Discussions
As far as learning on the QMS side, you should take an ISO 13485 lead auditor training course (and do it from a good company, exemplar global certified). Not only will that get you set up to perform audits, but will help you understand the requirements from the standard and think about where your current processes stand.
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