"Having worked with Sam to support our quality team, I am very happy to recommend his services to others. Sam was open and collaborative, able to engage with our various business and quality processes whilst providing helpful insights that we have used as part of our continual improvement process."

David Williams
Head of Quality & Regulatory at Crux Product Design

"It has been an absolute pleasure working with Sam for over a year now. Sam has a wealth of experience and knowledge in Medical Device Regulations spanning different device classifications and global markets. He has supported us in developing our Quality Management System and as we explore different regulatory markets for our medical device (including UK, North America and Europe). Sam is now our Authorised Representative and Internal Auditor against ISO 13485 and has been invaluable guiding us through the CE marking process so far. Always friendly and helpful with an efficient and proactive approach, I would definitely recommend Sam for any Medical Device Regulatory support and am excited to continue working together."

Jenny Appleton
Clinical Lead & CSO at Radii Devices

"Sam’s regulatory expertise was instrumental in guiding us through the successful classification and MHRA registration of our app as a Class I medical device. His ability to translate complex requirements into clear, actionable steps helped us build a robust technical file, risk documentation, and clinical evidence base, all within tight feasibility timelines. He brought precision, structure, and deep knowledge to a critical phase of our product journey.Sam’s regulatory expertise was instrumental in guiding us through the successful classification and MHRA registration of our app as a Class I medical device. His ability to translate complex requirements into clear, actionable steps helped us build a robust technical file, risk documentation, and clinical evidence base, all within tight feasibility timelines. He brought precision, structure, and deep knowledge to a critical phase of our product journey."

Justyna Strzeszynska
Founder & CEO at Joii

"Sam is a highly knowledgeable and engaging regulatory specialist. He has been instrumental in supporting the Medivys team gaining and managing our medical device classification and we look forward to continuing to work with him as our business grows. Thanks Sam!Sam is a highly knowledgeable and engaging regulatory specialist. He has been instrumental in supporting the Medivys team gaining and managing our medical device classification and we look forward to continuing to work with him as our business grows. Thanks Sam!"

Caroline Andrews
Founder, Medivys

"Sam has been great supporting Emm during our early development. He is aware of the constraints of startups and able to assist in a way that's viable for small businesses, flagging potential pitfalls and benefits of key decisions. He is also proactive in finding support for small businesses and open to exploratory discussions.

I'd definitely recommend speaking with Sam to see how he can support your company and roadmap. "

Joss Hawkins
Operations at Emm

"I have worked with Sam over the last year as he has guided us through the regulatory process for our FRAX fracture risk calculator in UK and EU. His knowledge, advice and guidance throughout has been invaluable in addition to contributing to much of the documentation required. His calm, measured approach to meeting the needs for the process has been incredibly helpful and has turned what appeared to be a very complex procedure into a very achievable one. This efficiency, combined with an excellent knowledge of the regulatory field and a very affable, relaxed personality, has made the whole process a very enjoyable and fulfilling venture. I really can’t recommend Sam highly enough. We are delighted to be able to continue to work with him on our project for the coming years. "

Eugene Mccloskey
Director of Osteoporosis Research Ltd

"Sam has been an invaluable advisor, particularly in guiding us through the regulatory requirements for Software as a Medical Device (SaMD). His deep expertise in this area has been crucial in ensuring we meet UKCA and MHRA standards. Sam’s proactive approach and clear understanding of SaMD regulations have greatly contributed to our progress. I highly recommend him to anyone in need of expert regulatory advice in the digital health space."

Gianpaolo Fusari
Head of Products & Platforms, Helix Centre

"Sam has helped to improve and support Peppy's ISMS across many years. He is particularly strong when supporting auditing compliance and preparation for ISO27001 surveillance and recertification audits. Sam is a very useful and flexible person to have around and is a pleasure to work with."

Evan Harris
CEO, Peppy

"Sam Bacon and his colleagues have been supporting our Company with our regulatory processes, administration and submissions over the last year, and have proved exceptionally efficient, helpful and effective. With their support we have made assessments on the classification of our medical devices, developed the processes, data and structures for managing the devices regulatory status, and submitted both UK and EU registrations - that have now both been granted. Sam has been quick to respond to queries. We look forward to continuing to work with Sam & Co as the Company moves forward to address regulatory compliance in other countries."

Kevin Dean
CEO, DName IT Ltd

"Sam did a fantastic job building our quality management system and helping us implement the necessary procedures to get our ISO13485. He gave clear, workable guidance on what we needed to do to meet the requirements of the standard, freeing up the team to focus on implementation and delivery, rather than trawling through paperwork. Would definitely recommend Sam to any other companies who are thinking of working with him."

Alasdair Price
CEO, Siloton Ltd

"We worked with Sam for our Software as a Medical Device (SaMD) UKCA Class I registration and for ISO 13485:2016 accreditation. He guided us through both without any hitches, with good humour, expert knowledge and his dedication was invaluable. Highly recommend seeking Sam out for your compliance and regulatory needs."

Zoe Blake
CEO, CareLoop Health Ltd

"As an SME medical device company based in the UK we have found the expertise and experience of Sam Bacon to be invaluable in interpreting new medical device standards, grappling with EUDAMED and generally using as a sounding board for our regulatory assumptions. Expertise in software as a medical device is a bonus! They are our EU Authorised Representative in Ireland, that are sensibly priced for SMEs. Couldn't recommend Sam highly enough."

Jessica Auton
Quality, Regulatory and Information Governance Director, Aseptika Ltd

"Myself and the Dynomed team were very fortunate to have worked with Sam developing our company's QMS documentation. On top of this Sam also guided us expertly through our first ISO application and eventual ISO 13485 Certification. It could have been a stressful and very overwhelming process but with Sam there, it was anything but. He brings great knowledge, calm and a can-do attitude to all things regulatory. I couldn't recommend Sam highly enough. And I still owe him a beer!"

Mark Rowe
Founder, Dynomed

"Sam has been an incredible asset to Mindstep, and I would recommend him to anyone without a doubt. He's worked with us across our UKCA and FDA medical device certifications, and throughout both has been extremely knowledgeable, efficient, and very communicative. His knowledge of medical device regulations, in combination with working with Mindstep across both projects, has meant he's only become more effective over-time, taking a huge load off of our team's plates."

Aaron Lin
COO, Mindstep

"Sam was an instrumental part Syndi Health’s journey to ISO 13485 and ISO 27001 accreditation. His knowledge of the regulations and standards was evident throughout the entire process, from the initial consultation to the final audits. Sam’s attention to detail and ability to guide us through the various requirements helped ensure that we were fully prepared for each step of the way. Sam's guidance was invaluable in helping us understand the intricacies of the standards and how best to implement them in our operations. The end result was two successful accreditations and a stronger, more secure business. We couldn't have done this all in the timeframe our customers required without Sam's expertise and support."

Ben Lakey
Syndi Health

"The entire Filter team was extremely impressed with Sam's knowledge, speed and professionalism while helping us achieve ISO13485 & ISO27001 accreditation. As a startup, compliance and regulatory can be nerve wracking but with Sam helping us, we were able to understand and implement a QMS and ISMS in a resource efficient manner. I don't think this would have been possible with Sam. Looking forward to continuing to work with him."

Andrew Gallagher, Co-Founder
Filter Health Limited

"A consummate professional, Sam is not just extremely knowledgeable, incredibly helpful and generous with his time, but also provides a level of calm that is needed when dealing with those relatively new to the complexity of standards and regulations. All these attributes were brought to bear recently by successfully guiding us through our ISO 13485 audit. As this was just the start of our ISO journey, I’m very much looking forward to working with Sam well into the future"

Michael Kaye, Head of Quality
EXI

"Sam helped us with our Medical Device documentation. He did this quicker than expected with thorough briefings and professional explanations. This all at a fair rate. His sense of humour was quite beneficial to make this a fun process. We would definitely ask him again."

Bertran van den Hoff, Operation Lead
Alt. Medical B.V.

"Sam has a wealth of knowledge and is a pleasure to work with. He and his team were instrumental in helping us achieve ISO 13485 accreditation and FDA registration, much sooner in our milestone plan than expected. We’re fortunate to have his guidance in navigating our regulatory pathway, his contributions have added significant value to our company. "

Dr Andrew Cameron, CEO
FeelTect Ltd

"As a Startup it was great working with Sam who understood our commercial and regulatory roadmap. Sam was a fantastic help with our ISO 13845 Certification Project and I would enthusiastically recommend him to other Startups in need of quality or regulatory support for their medical device or software."

Dan Daly, CEO
Occuity Ltd

"As a seed stage digital health company staying on top of our regulatory and ISO standards is critically important for us. Getting these things right at the early stages will ensure we can meet the requirements of our customers in the future. Sam has been instrumental in getting us over our first regulatory hurdle, the last step in getting our first customer. The team have provided ongoing support to help us plan our roadmap for the next year and beyond."

Shona D’Arcy, CEO
Kids Speech Labs

"I had the pleasure of working with Sam and was thoroughly impressed with his knowledge and expertise in (UK and EU MDR) regulatory affairs. Not only did he expertly guide us through the regulatory maze, but was instrumental during our external ISO 13485 Certification Audits and helped us achieve a successful outcome. His deep knowledge of the industry, attention to detail, and can-do attitude makes him a valuable asset. I recommend getting in touch with Sam, if you need support in the medical device field."

Will Jackson, CEO
Play Physio CIC

"Sam was a great help to our company as we were preparing for our last ISO 13485 audit. We look forward to working with Sam on future regulatory projects."

Una Kearns, CEO
myPatientSpace

"Sam and his team were fantastic to work with! They are flexible and deliver work very quickly. They also invested time in providing in-depth team training and support throughout the process. They acted professionally and delivered a high quality service. I am confident in continuing to work with them as we scale and grow."

Carolina Bell, Business and Finance Lead
Neurovirt

"I was impressed how Sam worked effectively, independently producing our new MDR compliant Technical Files and Risk Management documents. We have also utilised his EU Representative Service to ensure continued market access for our devices into EU countries."

Simon Upton,Owner
Rapidex Ltd

"Sam provided training in some keys areas for myself and colleagues. He was professional, very helpful and we all came away with a greater understanding. We picked up some memorable hints and tips going forward to assist in an even clearer and concise way of working. He answered all our questions in detail. Would highly recommend."

Caterina Buono, Quality Assurance and Regulatory Affairs Specialist
Medicina Ltd

"Sam has made our journey into MDR straightforward and stress free. His approach is helpful and friendly yet thoroughly professional. He has made the whole MDR experience much less daunting than it might otherwise have been. Thoroughly recommended."

Dave Gilbert, Managing Director
Pretorian Technologies Ltd

"Without doubt, this is one of the easiest recommendations for me to give after working with Sam on several quality and regulatory projects successfully completed spotless and on time. In a nutshell, he is a five-star professional and one of the most enjoyable collaborators I have ever had the pleasure to work with. He is the type of consultant who goes the extra mile for his client, restless in offering support, adding value through his knowledge, experience, and balanced approach to everything he does."

Michael Ponde, Quality Manager
Safety First Aid Group Ltd