WHAT WE DO
Navigating medical device regulation can feel complex. With the right expertise, it becomes a defined, manageable process. Our team of experts has an in-depth knowledge of the regulatory landscape and can guide you through the process of obtaining the necessary approvals and certifications to place and keep your device on the market.
WE DELIVER
Focused, end-to-end support to demonstrate the safety and performance of your devices. Each service is delivered with the same approach: clear, compliant, and aligned with current regulatory expectations. By providing you with practical support across your regulatory journey, we support you at every stage - so you can move forward with confidence.
We write MDR-compliant clinical evaluation reports aligned with MDCG guidance.
We prepare PSURs supporting regulatory compliance and medical device safety.
Our SSCP services support MDR compliance, safety and clinical performance.
We provide risk management supporting compliance throughout medical device lifecycles.
Our PMS services support regulatory compliance, safety and continuous improvement.
We develop biological evaluation documentation supporting compliance and patient safety.
We deliver sterilisation validation supporting microbial control, safety and compliance.
OUR EXPERT TEAM
Meet some of our dedicated professionals committed to enhancing healthcare solutions and improving patient outcomes.
Chris Hands
Director & Founder
As Founder and Principal Consultant of Hands On MedTech, Chris brings over 18 years of experience in the medical device industry.
Sally Sennitt
Associate Consultant
Sally is a Medical Doctor with 20+ years' experience in anesthesia, regulatory affairs, and laboratory management. She has a MSc in Medical Device Regulatory Affairs.
Kelsey Roberts
Associate Consultant
Kelsey is a regulatory affairs leader with 9+ years’ experience driving global medical device strategy and delivering an exceptional number of FDA 510(k) clearances.
HOW WE WORK
Regulatory work isn’t just about documentation; it’s about judgement, interpretation, and experience.
Our team brings deep industry knowledge across regulatory affairs, clinical evaluation, and post-market activities. We don’t apply generic templates. We work closely with you to develop solutions that are tailored to your device, your data, and your regulatory pathway.
OUR CLIENTS
We work with organisations across the medical device sector from manufacturers and importers to distributors - spanning a wide range of specialties, including cardiovascular, orthopaedics, and beyond. While each organisation is different, they share a common goal: to deliver safe, effective devices while meeting increasingly complex regulatory requirements.
That’s where we come in.
Our clients range from early-stage startups to established global companies. In every case, we take the time to understand your device, your objectives, and your regulatory pathway - so the support you receive is tailored, practical, and aligned with what’s expected. Here’s what that means for you: clear guidance, structured support, and the confidence that you’re moving forward in the right way.
30-MINUTE REGULATORY CLARITY CALL
Get clear, expert insight into your medical device regulatory strategy in a no-strings-attached 30-minute call. Whether you’re preparing for EU MDR, UKCA, or global submission, this session will quickly highlight where you stand - and where you can strengthen your approach.
Bring one live question about your device, evidence or documentation. We’ll clarify where you are, identify the next two or three priorities and decide what a sensible next step looks like. No pressure and no obligation to engage us.
CONTACT
Let’s talk about your regulatory pathway.
Whether you’re preparing for certification, updating documentation, or responding to notified body feedback - we’re ready to support you.