Regulatory strategy and support.
Giving you regulatory confidence from concept to market
Our Regulatory Affairs and Quality Management team ensures medical devices meet the highest standards of safety, effectiveness, and compliance. Accredited to ISO 13485, we support every stage of the product lifecycle, from development to market approval - helping you navigate complex global regulatory landscapes with confidence.
Our ISO 13485 certification for medical device development shows our commitment to a high quality Quality Management System. It also shows our ability to consistently provide well structured and documented processes that drive overall product quality from initial concept, all the way to launch, especially for high-stakes, regulated environments like healthcare and security.​​​
We Mitigate Risk Through Design
Delivering results through what we do best...
Risk
management
Design
verification
User
testing
Change
logs
Document
control
Regulatory
compliance
Design history
files
Device master
records
Design to mitigate use-related risks
Human Factors Engineering ensures that products are safe, effective, and easy to use - by real people, in real-world settings. It focuses on how users interact with a product to achieve their goals efficiently and safely. We identify risks, prevent misuse, and help avoid safety issues before they happen.
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Our expert team focuses on these core activities:
Understand user needs, pain points & opportunities
By collaborating with a UX team early on, we conduct user research to uncover who the users are, how they interact with the product, and where they use it. These insights reveal pain points and potential risks - so we can solve problems before they happen.
By identifying these issues upfront: we design smarter, safer solutions from the start - saving time, money and reducing rework.
Analyse, identify and mitigate usability risks
We often begin with a draft IFU (Instructions for use) to map out how the product is, or would be used in real-world settings. This early step helps inform risk management by revealing potential hazards and critical tasks. Our team collaborates to define effective risk controls, including user interface specifications.​
The goal: create clear, actionable solutions that keep risk within acceptable limits.
Design, test, refine - repeat
By exploring multiple design options and testing early concepts through formative evaluations, we uncover what works and what doesn’t. This ensures medical devices are not only safe, but also intuitive, efficient, and aligned with how people actually use them.
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These evaluations go beyond the product itself. They help refine instructional materials and training tools - like the Instructions for Use (IFU). which are essential parts of the user interface. By testing how users interact with these materials, we make sure the entire experience supports safe and successful use.
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The result: well-informed design decisions, reduced risk, and products that truly support users from first interaction to daily use.
We’re committed to your product safety and quality assurance.
We help ensure your medical device meets the necessary regulatory requirements for FDA approval by applying rigorous human factors engineering principles throughout the development process.
As an ISO 13485 certified organisation, we adhere to internationally recognised quality management standards, reinforcing our commitment to safety, usability, and compliance. Our approach minimises risk, accelerates time to market, and supports successful regulatory submissions
