Quality Management Systems (QMS)
A QMS That Works for You, Not Against You
A quality management system (QMS) is more than a pile of documents. Your QMS is the backbone that shows how you consistently produce medical devices that are designed, built, and tested with patient safety and regulatory compliance at front-of-mind.
A challenge for most startups is that QMS requirements can feel complicated and heavy, especially if the team has no QMS experience, or is trying to balance product development with limited time and resources.
That's Where I Come In
Whether you need to build a QMS from scratch, move from a bootstrapped system that no longer works, or optimize what you already have, I will help you design and maintain a quality management system that supports your company instead of slowing it down.
I tailor my approach to your team and your product because what works for a global pharma giant probably won’t be the best fit for your startup.
Together we’ll answer questions like:
Should I make my QMS using software, paper or a combination?
OMG there are so many QMS softwares - how do I know which one to choose?
Can I take advantage of any existing software I already pay for and am familiar with?
The goal is always the same: a quality management system that feels clear, usable, and scalable.
Just Getting Started? Let’s Keep it Simple
If you’ve been thinking (or maybe dreading) that it’s time to start setting up your QMS, there’s a good chance you’ve got the PDF of ISO 13485 open on your computer but have no clue where to start. You’ve probably heard terms like “ISO 13485” or “quality assurance” but if you’re new to this space, translating that jargon into action is another story.
What Does Simple Look Like in Practice?
Building it Right from the Beginning
Together, we set up your first QMS processes, focusing on what matters most right now while planning for what you will need later.
You probably don’t need to start with everything everywhere all at once, so I’ll help you plan out a phased approach that makes sense with your resources, goals, and timelines.
We’ll keep it lightweight, clear, and practical so you and your team can focus more on developing your product and less on feeling stuck in the compliance weeds.
Need Help Navigating Compliance?
Already Have a QMS System? Let’s Untangle It
If your company already has a QMS in place but it feels clunky, outdated, or impossible to maintain, you are not alone.
Many startups and scale-ups find themselves with systems that grew too quickly or were set up just to “get through an audit.” The result is usually a patchwork of processes that no longer serve the team.
Or maybe you went overboard at the beginning, and are now drowning in a sea of CAPAs, audit findings, and nonconformances before your product is even out the door, leaving your team frustrated and overwhelmed.
This is where I step in to help you untangle the mess!
What can I do?
Fixing What You Inherited
Stuck in a trap of outdated processes that don’t match how you operate? Have a pile of partially written SOPs that never seem to get finished?
I can help you make those processes and SOPs into something that works for you.
Spot the Gaps, and Simplify the Rest
I review what you have, identify gaps, and simplify where things have become overly complex.
Partnering to Build a Stronger QMS
I’ve seen the power of a strong QMS, and I’ve seen the risks of a weak one.
I am not here to drop in, hand you a binder of procedures, and then disappear. I want to work with you to build, fix, or optimize a quality management system that makes sense for your company and supports your long-term growth.
Audit Support
I’ll help you prepare for ISO 13485 and MDSAP audits, giving you confidence that your QMS will hold up under scrutiny and that your team is ready to defend it.
Keep Improving Without Burning Out
Together we’ll turn your QMS into a living system that grows with your business, instead of something you revisit only when auditors are coming.
The goal here is not to add more red tape. It’s to create a QMS that your team can actually use every day. One that builds confidence with regulators, investors, and partners while giving you more time to focus on your products, patients, and making the world a better place.