Navigating regulatory approval doesn't have to be complicated
We deliver regulatory consulting for the manufacturer, rather than through a dry application of the rules. We identify and solve core issues preventing full approval, applying a unique combination of clinical, regulatory and medical device expertise.
Targeted insights from our specialists add value throughout each project, driving product traction alongside approval.
Paul's background as a clinician and medical device developer underpins his commitment to placing quality devices in the hands of people who need them. He has industry experience at start-up, mid-size and multi-national level. His combination of clinical, legal and medical device experience means he is uniquely positioned to lead the delivery of our market-leading consulting services.
For over two decades, Richard has worked with organisations to design and develop digital platforms, manage technical infrastructure and ensure the smooth operation of their critical business systems. His experience in digital and medical device startups gives him a great perspective to direct Mantra Systems' core systems.
Sandra is a biomedical engineer with a strong medical device background and years of Regulatory Affairs experience. She obtained a Master's in biomedical engineering from Newcastle University, specialising in biomechanics and medical device regulation. Her background and comprehensive experience have equipped her with a deep understanding of both technical and regulatory aspects of medical device development.
Gayle is a qualified medical doctor, with 17 years of experience in various areas of the medical field, having worked in both government healthcare and private practice. She founded and ran her own medical practice for 9 years. Gayle began her medical affairs career as a trainee on the Mantra Systems' Associate Program and is now our Chief Medical Writer.
Simon is a qualified medical doctor with 4 years of experience across multiple hospital specialities. Whilst predominantly working in the Emergency Department, he also has experience in anaesthetics, critical care, and general internal medicine. Simon spent 18 months working on Mantra Systems' Associate Program before joining the core team as a Lead Medical Writer.
Our services are smart, efficient and tailored to your needs. That’s how we take the complexity out of medical device compliance.
Tailored support to secure UKCA or CE-marking for your medical devices.
CEP & CER writing services with success across 250+ submissions spanning all risk classes.
Ensure your in vitro diagnostic medical devices gain first-time IVDR approval.
Bringing a medical device to market is a challenging journey. We know — we've been there.
After 13 years working as a medical doctor, our CEO Paul Hercock and co-founder Richard Jones were striving to develop and market novel infection control devices intended to reduce infection spread in acute care.
The concepts were solid, the business was well-funded and the IP was secure; however, there was a problem: navigating regulatory approval without sufficient understanding or access to support meant too many wrong turns, which ultimately proved a barrier too far.
From the ashes of this early setback, a key question remained - how many other great devices fail because regulatory hurdles prove too challenging?
And, more to the point - how can medical device manufacturers access the support they need?
To get an answer, Paul immersed himself in the medical device industry, working for established companies in Medical & Regulatory Affairs.
Gradually, and especially in view of the introduction of the EU MDR, a picture emerged of a need to marry regulatory professionals with medical experts who could skillfully generate, understand and apply clinical evidence effectively.
Perhaps this combination, delivered through a personalised and collaborative approach, might enable more great products to reach the people who need them…
Fast-forward to the present day and this unique blend of regulatory and medical expertise remains at the core of our business.
It means we can help our clients navigate complex regulatory pathways while advising on clinical data and instantly grasping the finer details of the target medical field.
It means a natural ability to deeply appraise clinical evidence while remaining balanced, objective and professional.
It means a forward-thinking, approachable and diverse team with an ingrained commitment to world-class communication and utmost professionalism.
It means a 100% submission success rate under both EU MDR and EU IVDR, with a commitment to stand behind each and every submission until complete acceptance.
It means a rapidly-growing team and a global client base, with over 200 successful submissions to date and a 77% rate of returning customers.
More than anything, it means a perfect blend of skills and expertise to understand your products, your customers and your objectives, and to plan and deliver a market access strategy engineered for your success.
It means a new approach to medical device consulting and we look forward to being part of your journey.