QMS DEVELOPMENT FOR THE FIRST TIME IN A SMALL MEDTECH STARTUP

[n.cherukuri]

Hello,

I’m reaching out in the hopes of connecting with a mentor who can provide guidance as I work through building and implementing a QMS for a small but growing medical device startup.

By way of background, I come from a Regulatory background, having graduated recently and previously worked on medical device post-market complaint handling and annual registration for class 1 and 2 . There, I focused on regulatory submissions and compliance. However, I recently made the transition into an industry role as the Regulatory Affairs Specialist medical device company with a wearable device and their first FDA submission with no QMS in place and no knowledge about regulatory or FDA. While I have a strong foundation in regulatory requirements, I recognize that I'm still building my “boots on the ground” experience, particularly in setting up and operating a manual QMS in a lean startup environment.

I’d appreciate any mentorship or even occasional guidance on real-world implementation.

If anyone is open to connecting or pointing me to key threads or resources, I’d be extremely grateful.

Thank you in advance for your time and support!

 

[Ed Panek]

So not having a QMS in place is possible for submission (As long as there's clear document controls on the records), but when FDA visits, a QMS is required.

I work in a small start up. We are ISO 13485 (2016) and recently MDSAP US, Canada and Australia. We are also CE marked.

If I were starting over an early exercise is to draft a year one budget for approval by CEO or BoD. Identify major gaps from where you need to be and list them. How you plan to address them, internally or externally and a SWAG at costs. Without money you will really struggle.

Now, with your budget in mind, invoke your Year 1 plan. Itemize what needs to occur first. This might include SOPs, suppliers, test data, or finding a notified body, depending on your goals. Create a document control system, and begin to develop areas of the QMS. You can use the ISO standard or 21 CFR 820 from the FDA, but your QMS must address those items.

Create a Quality Manual. Define a Quality Policy that makes sense. Dont create one too abstract. Just identify what you currently do to create customer interest and satisfaction. In the QM define the nature of your business. Identify exemptions to requirements. Include a table cross-referencing the standard(s) and your QMS documents that address each one. This makes audits easier.

Figure out your complaint/feedback system. FDA is big on that. CAPA SOPs and Non conforming product is another big FDA item.

If FDA approves your device and they come to audit they have already seen your design documentation. Its possible they ask about it but more than likely they're going to hit your operational work harder. Training, testing in production, Shipping controls, Raw materials etc.

Theres a lot more but this might help get you started.

 

[LUFAN]

Hello,

I’m reaching out in the hopes of connecting with a mentor who can provide guidance as I work through building and implementing a QMS for a small but growing medical device startup.

By way of background, I come from a Regulatory background, having graduated recently and previously worked on medical device post-market complaint handling and annual registration for class 1 and 2 . There, I focused on regulatory submissions and compliance. However, I recently made the transition into an industry role as the Regulatory Affairs Specialist medical device company with a wearable device and their first FDA submission with no QMS in place and no knowledge about regulatory or FDA. While I have a strong foundation in regulatory requirements, I recognize that I'm still building my “boots on the ground” experience, particularly in setting up and operating a manual QMS in a lean startup environment.

I’d appreciate any mentorship or even occasional guidance on real-world implementation.

If anyone is open to connecting or pointing me to key threads or resources, I’d be extremely grateful.

Thank you in advance for your time and support!

Send me a PM. I’ve built multiple QMSs from day zero for start ups. Happy to answer questions and provide guidance.

 

[Enternationalist]

Your first two jobs are getting emotional buy-in, and getting use out of basic procedures. Don't need to bite it all off at once. Sit down with your stakeholders, go through the standard and allocate sections to different procedures. Allow them to arrive naturally at conclusions like "let's put all the change control stuff in one section". Provide guidance but let them play a bit in how to divide up things.

Get a quality plan sorted with some generally roll-out strategy and get them going pretty quick on basic formal activities like document control. Don't overcook it. Remember, you don't have a device in the market yet. Not all of your procedures are going to come online at once. Allow them to make mistakes and correct them through a reasonable NC process. Allow them to make changes.