Regulatory Strategy & Compliance Support
Turn Your Regulatory Maze Into a Map
Regulatory compliance can feel like a moving target, especially for medtech and life sciences startups balancing growth, funding, and product development. The rules often feel overwhelming, full of acronyms and written in a way that makes it hard to see how they apply to your specific company.
My role is not to bury you in jargon or hand over a binder that you will never use.
Instead, I work alongside you to create a clear, practical path toward compliance that makes sense for where your company is today and where you want it to grow.
Whether you’re figuring out which regulations apply to your medical device, preparing for an MDSAP audit, or working toward ISO 13485 certification, I’ll guide you through what’s required and how to achieve it. All without losing sight of your product roadmap and business goals.
Regulatory Strategy and Compliance are Not One-Size-Fits-All
Every company has its own products, team structure, and goals, which means the right approach for you may look very different from the company down the street.
What Do I Bring to the Team?
My role is to meet you where you are, guide you through the requirements that matter most, and make sure the systems you build actually work in practice. That includes:
Big-Picture Guidance Without the Guesswork
Is your product even a medical device?
From your very first regulatory questions to long-term planning, I help you map out a tailored strategy that fits your product, your company, and your team.
The goal is to give you clarity on what matters now and what can wait so that you can make informed decisions with confidence.
Documentation that Does Its Job
Regulatory documentation can feel like an endless paper chase that never leads anywhere. I guide you through creating what you actually need, from quality manuals and SOPs to submission-ready records.
Together, we make sure your documentation is accurate, useful, organized, and aligned with the right requirements. No guesswork, no busywork, just straightforward preparation that saves time and reduces stress.
Audits Without the Panic
Getting ready for an ISO or MDSAP audit can feel intimidating, but it doesn't have to!
I will walk you through what to expect, step by step, and make sure your systems are compliant, practical, and effective in real life. Along with reviewing your documentation and processes, I also provide audit-readiness training for your team.
We cover what to expect during an audit, how to understand and answer auditor questions, and what to do when you don't know the answer. Your team will learn best practices for communication, professionalism, and staying calm under pressure.
When audit time comes, I want you to feel prepared, not panicked.
Clinical Trial Support
Protocols, informed consent forms, case report forms, and study management software. These elements of clinical trials carry their own set of expectations, and it can be challenging to know where to start.
I’ll help you write, design, and review trial documentation so that your studies are both compliant and comprehensive. This way, you can focus more on gathering high-quality data and less on worrying about whether you are missing a critical requirement.
Building a Quality Management System That Grows With You
Every company is on its own journey, but most follow a similar path. I help you move along that path with a QMS that make sense for your team:
The Early Stage
At the beginning, the goal is clarity with the basics. You may be wondering which regulations apply, how soon you need to think about MDSAP compliance, or what ISO 13485 will eventually mean for your company.
Together, we focus on the essentials and set up simple, lightweight systems that support your product development without slowing your progress. I’ll help you set up a strong foundation without creating unnecessary bureaucracy.
Quality and regulatory activities at this stage typically focus on:
Defining what the product will be used for and where it will first be sold
Setting up and using processes and procedures for:
Document Control
Design Control and Risk Management (product development)
Training
Audit Ready
Eventually, the time comes when auditors will want to see evidence that your QMS is not just written down, but is being followed and working in practice.
Here, I guide you through the details of certification readiness and audit preparation. From reviewing documentation to supporting mock audits, I make sure you feel confident and prepared to defend the integrity of your work.
By this stage, compliance is no longer something you are scrambling to meet at the last minute. It is simply part of how your company operates.
Scaling
As your team grows and your product pipeline or market reach expands, the systems that worked in the founder’s basement may start to feel stretched.
At this stage, I help you strengthen and optimize what you already have. That might mean:
Adding in new processes like Complaint Handling to your QMS,
Making an existing process more user-friendly or robust, or
Preparing for clinical studies to gather data for new products.
The focus is on keeping your QMS compliant, right-sized, and aligned with your company’s growth so it continues to serve you instead of being a roadblock.
Let’s Talk About Your Regulatory Maze
I am not here to certify your QMS, give you permission to sell your product, or replace your legal counsel. I am here as your partner, helping you understand the rules, apply them in a way that makes sense, and build systems that support your company’s growth.
Together, we can turn regulatory compliance into a foundation you can rely on rather than a hurdle that slows you down.