Risk Management & Product Design Support
Compliance That's Built In, Not Bolted On
In the world of medical devices, it’s not enough to design a product that works; you also need to prove that it is safe, effective, and reliable in the real world.
But too often, maybe because of inexperience or lack of resources, risk management is treated as a last-minute scramble. Instead of finding, documenting, and controlling risks through the product’s entire lifecycle, risks are treated as a one-and-done activity and put aside until right before an audit or submission.
I take a different approach
By integrating risk management directly with each step of product design and development, we can build safety and effectiveness into your products from the very beginning.
I take a cross-functional team approach to product design, development, and risk activities. The goal is to collaborate, gathering input and feedback about your product from a wide range of sources as it is designed, tested, and eventually sold.
Inside (Company) Sources
Representatives from all parts of your company that have a stake in the product need to have a voice. Marketing, Sales, Medical Affairs, Clinical, Regulatory, Customer Support, Servicing, Quality, Development, Supply Chain, etc.
Outside Sources
Include representatives from product stakeholder groups that are not part of the company. Device Users, Patients, Patient Advocates, Key Opinion Leaders, Academic Researchers, etc.
Why does that matter?
An unfinished picture of what your device needs to do, who needs to use it, or how/where/when it gets used means your team might make assumptions, ask the wrong questions, or look for answers in the wrong places.
Ultimately it means you’re likely to miss finding some of the risks in your product or put safety measures in place that don’t actually make things safer. And that means patients and users might get hurt.
Your sales might slump.
Your product might get recalled.
Your business’s reputation might fall.
If things get really bad you might have to stop selling your product, shut down your business, or even go to jail.
Those are scary thoughts. But to me what’s even scarier is putting a product on the market where I haven’t tried my best to use all my resources and know-how to make it safe.
Taking a cross-functional integrated approach like this has other benefits, too. It saves time, reduces stress, and helps you avoid costly product redesigns, last-minute testing, or other gaps that could increase your time to market.
Confused About Compliance?
Catching Risks Before They Catch You
Every product comes with risks
Yes, even bandaids, face masks, and software.
And if you don’t think about what those risks are until an auditor is knocking at your door it will be too late to do anything about them.
Medical device risk management is a comprehensive process. Identifying hazards, harms, and hazardous situations. Scoring severities and probabilities. Thinking of ways to reduce risks. Making sure your steps to reduce one risk don’t actually increase a different one. And on and on, documenting all of it.
An early start, clear organized documentation, and a cross-functional team are critical to doing this right.
The good news is, the concepts are the same no matter what your product is! Hardware, software (SaMD, Software as a Medical Device), or a mix of both (SiMD, Software in a Medical Device) - it all has to go through risk management.
Whether your product is cloud-based, app-based, or hardware-driven, I'll help set up a proactive risk management framework aligned with ISO 14971 and other relevant requirements.
Managing Risks Early Saves Headaches Later
Ignoring risk management until the last minute often leads to surprises, delays, and costly fixes.
When you embed risk management into your product design from the start, you build systems that scale with your company and strengthen your competitive edge.
Investors, partners, and regulators take notice when your risk management is thoughtful, consistent, and reflects an understanding of the regulatory requirements. They’ll also see your commitment to the safety of patients, healthcare providers, and anyone else who uses the device.
Risk Management is More than a Spreadsheet
Think of me as a hands-on partner who helps you anticipate and address issues before they become roadblocks. I won't hand over a generic hazard analysis spreadsheet and disappear.
Instead, I work closely with your team to:
Identify risks early in product development
Align risk controls with design and usability requirements
Ensure documentation is accurate, complete, and audit-ready
Support continuous improvement as your device moves from prototype to market
This proactive approach means fewer late-night scrambles before audits, smoother regulatory submissions, and a team that feels confident in the safety and quality of the product they are building.
From Risk to Readiness
Risk management is not just a regulatory requirement. It is a way to design better, safer, and more successful products. Whatever your product, I can help you build risk management into the DNA of your company.