Helping Medtech Startups Build Compliant, Confident Systems
At BH Quality Management, my mission is simple: to make regulatory compliance and quality management accessible and uncomplicated for medtech startups.
What Does That Mean?
Making Regulations Simple (and Doable)
I help you and your team figure out:
Which government rules apply to your company,
What systems you’ll need to follow those rules, and
How you can collect and store evidence to prove your product is safe, effective, and was made following those systems and rules.
I design and integrate regulatory and quality systems in a way that makes sense for you, your company, and your product.
Whether you’re a team of 5 in the founder’s basement or a group of 100 spread over the world, your company is unique and deserves a tailored approach to regulatory success.
This means you get to feel confident, audit-ready, and focus more of your energy and time on creating life-changing products.
Less Bureaucracy, More Breathing Room
I know how overwhelming it can feel to hear you need to be “FDA compliant” or “MDSAP certified”, especially for early-stage companies that are juggling growth, investment, and product development with time crunches and limited resources. That’s why I bring a collaborative, practical approach.
From ‘Ugh’ to ‘Okay, That Makes Sense’
My goal isn’t to bury you in jargon or tell you what you can’t do. Instead, I take a more “Yes, and” approach, working alongside you to build systems that are compliant, effective, and scalable. The types of systems that give you the confidence to grow without worrying about being caught off guard.
Meet Becki
I’m Becki, the founder of BH Quality Management. I’ve built my career around helping startups in the medtech and life sciences space navigate regulatory and quality challenges.
What makes me different is my focus on transparency, integrity, and authenticity. I care deeply about empowering founders to understand the systems they’re building, rather than creating dependence on outside consultants.
Ways I Can Help You
At BH Quality Management, I support medtech startups and founders with practical, hands-on compliance guidance.
Whether you need a regulatory strategy, a QMS tailored to your company’s stage of growth, or a trusted partner to step in with fractional leadership, I meet you where you are and help you move forward with confidence.
Your Roadmap to Compliance
Get clear guidance on documentation, certification readiness, and audit navigation.
Quality by Design, Not by Chance
Proactive risk management integrated into your SaMD, SiMD, or hardware product design processes to avoid unexpected patient harm and last-minute scrambles.
Empower Teams to Lead with Quality
Onboarding for new hires and building a quality-first culture.
Build a QMS That Actually Works
From paper-based systems to an eQMS, I’ll help you create and optimize quality management processes that work for, and grow with you.
Step Into Leadership When You Need It
Fractional or interim QA/RA leadership, plus coaching for your team.
Who I Work With
I partner with innovative life sciences and medtech startups who want to build strong foundations for success. From first-time founders to scaling teams, I collaborate with people who are ready to take compliance seriously and turn it into a competitive strength.
Let’s Talk About It
If you’re ready to feel confident in your regulatory and quality systems and grow without second-guessing compliance, I’d love to help. Let’s talk about where your startup is today, where you want it to go, and how we can build the right systems to get you there.