What people are saying about QMS Consultancy
Alex Rothwell, CytoLearn
Navigating medical regulations was a daunting prospect, but Rich provided us with a comprehensive QMS and TFT. Rich's training was thorough, straightforward to follow, and flexible to meet our needs. Even since the training, Rich has been responsive and always on hand to help.
Long term, the system will prove invaluable. In the short term, the training has helped us establish a clear route to market and has been instrumental in helping us raise further funding.
Cornelius Palm, Happyr Health
"Richard's expertise and patience in navigating the complex topic of medical device regulation, coupled with his unique QMS setup, provided us with the confidence and clarity needed to successfully navigate the process for Happyr Health. We highly recommend Richard for his exceptional guidance and deep knowledge in this field."
Jane Theaker, PBD Biotech
Richard’s suite of documents and the training he provided to us are the solid foundations of PBD Biotech Ltd’s quality management system (QMS). It has meant that our Quality manager and our team can concentrate on adapting the documentation templates to suit our product, rather than writing a quality system from scratch, saving many hours of work. It also means that our QMS has been designed with best practise in mind, built from Richard’s years of experience in medical devices and diagnostic products. I estimate that what Richard has provided will save us months, if not years, of time and effort in creating our FDA submission for our Actiphage TB blood test.
Brigette Bard, BioSure (UK)
"I could not recommend QMS Consultancy highly enough. Richard’s insightful approach and incredibly efficient QMS has transformed our business and helped us to quickly grow into a multinational organisation. He is a pleasure to work with."
Rich Savage, PinPoint Data Science
"Rich was brilliant for us. He worked with us during a real crunch period where we CE marked 9 products simultaneously to a deadline, and his help, support and expertise were the difference between making that deadline and not doing so. The depth of experience he brought was key for us, and he was extremely good at understanding the challenges of our particular products and finding rigorous ways for us to meet the regulatory requirements. I would absolutely recommend working with Rich to anyone in this space."
Warren Macdonald, Senior Teaching Fellow, Imperial College London
“I have known and worked with Rich since 2018, during which time he has provided expert advice and assistance to MSc students of the Medical Device Design and Entrepreneurship module. Rich’s knowledge and experience in dealing with Medical Device Regulation is extensive, thorough and up-to-date. He has guided our students through the complexities of understanding the relevance and impact of the Regulations on their widely diverse projects, and patiently assisted them with adopting the optimal level of activity. Rich’s connection with the students was excellent, his lecturing style clear and accessible.”
Kate Toms, Digital Health London
"Thank you very much for your presentation today, and the follow up 1:1s. The feedback we had from our Accelerator SMEs was fantastic - they rated an average of 9/10 in terms of quality of content and all agreed that the session met their learning objectives. When asked to report one thing that they found useful from the event, they provided comments such as; how UK uses MDR in the future, excellent detail, very informative and useful."
George Thomas, Bea Fertility
As a first-time medical device manufacturer, learning and navigating the regulatory landscape to get our products to market is a considerable challenge. Working with Richard and QMS Consultancy to get a robust and comprehensive QMS in place has been one of our best investments. The QMS ensures we have everything in place to meet the requirements of ISO 13485, but it is much more than a box-ticking exercise and genuinely helps us make the right decision every day to guide our medical device development.
Annie Ng, Kheiron Medical Technologies
"We worked with QMS Consultancy to support ISO 13485 certification. They helped us go from implementation of our QMS to completion of our stage 1 audit in record time with no non-conformances."
Gemma Wilson, Sarissa Biomedical
“We worked with QMS Consultancy to support our creation of a QMS to ISO13485 and an IVDD Technical file. Rich was able to offer a tailor-made solution to supplement existing systems and documentation which enabled us to achieve our ISO13485 certification in a short period of time.
He is very knowledgeable and a pleasure to work with. I would recommend QMS consultancy to others seeking certification to ISO13485 and would work with him again.”
Mac Tuncer, Alloyed
"Richard’s QMS & TFT has been instrumental in our ambition to develop our systems and launch our new business within a short period of time. The system is well structured and with Richard’s help we customised it to work for our own requirements. We also used Richard’s network of industry contacts to speed up our development. I am delighted to say that we successfully passed our ISO 13485 audit on our first attempt and the process was smooth and straight forward. I would certainly recommend QMS Consultancy."
Adam Kemp, Otodynamics
"We have been working with QMS Consultancy since 2018. Richard has been more than a consultant, he has become part of the team and facilitated a much-needed change on our quality assurance approach, documentation and mentality. Working with Richard, we have benefited from his in-depth knowledge of ISO and his experience. Through the many companies Richard has represented, he has gained a balance of regulatory requirements and efficiency. Previously our quality assurance attitude was to satisfy an auditor, it now looks to deliver ‘real’ quality assurance, doing the right thing at the right time, creating added value rather than a cost. Richard has been instrumental in developing a company culture that QA is not a department its part of each employee’s role that satisfying the auditor as a by-product."
Jonathan O'Keeffe, Machine Medicine
"Richard supplied us with his QMS, which accelerated our progress towards class 1 status, I would estimate, by 6 months to 1 year. In addition to that it allowed us to be prepared for a customer audit, a customer who subsequently signed a $75K contract with us. This even before class 1 status was obtained. However, perhaps where we have been most appreciative of Richard is in his ongoing support, by email, phone and in person, which has allowed us to pupate from a company that HAS a QMS to a company that actually actively and authentically utilises one, a profound transformation. On top of all this, he is a thoroughly professional and personable expert-in-his-field and we anticipate and look forward to a long a productive relationship with him."
Sorin Popa, Pathfinder Medical
"Over the past 5 years Rich has helped us grow from a research focused spin out into a fully fledged medical device company with inhouse manufacturing capabilities and CE regulatory approval. In addition to helping us set up our QMS, Rich has provided us ongoing support over the years and helped us pass three ISO13485 audits to date. Rich has a business focused mindset and ensures that our QMS system is implemented in such a way to best drive technical and commercial development and streamline regulatory approval processes. Overall, Rich is a pleasure to work with and I highly recommend QMS Consultancy."
Matt Pearce, Medtechtomarket
"We have benefited from working with Richard for over 20 years. QMS Consultancy has helped with navigating us around the initial accreditation and developing ongoing relationships with the notifying bodies. Through QMS Consultancy, our team have developed the skills for managing the system, and helped us to achieve a first class and robust quality management system that not only provides us with workable, traceable and compliant product development and manufacturing processes, but has also stood up to numerous audits, inspections (including unannounced CE, and FDA inspections) and due diligence inspections from major multinational companies."
Tom Richardson, Acceler8 Clinical Research, Singapore
"Without doubt, Richard is the go to person in the industry to help provide intelligent, robust, highly accurate systems to take medical device companies onto their next milestone. Whether it be a fully functioning Quality Management System, a highly tailored Technical File or curated consultancy based on your needs, Richard will give you the time, energy and commitment that you require to ensure you won’t worry about passing your next audit or inspection."
Kiran Roest, Vital Signs Solutions
"QMS Consultancy has guided us along our path from a research-driven start-up to a QMS-13485 certified digital medtech company. Richard is a valuable contributor to our team and his easily-navigable, flexible and robust QMS structure helped us efficiently and effectively put in place processes to ensure we meet all the regulatory requirements associated with our portfolio. His confident nature and passion and enthusiasm for regulatory matters makes working with him a pleasure."
Richard Hall, PD-M Product Design
"Richard is pragmatic, knowledgeable and applies practical common sense to what can be a very challenging regulatory area for organisations to understand."
Marie Labus, CEO AMLo Biosciences
"I first met Richard in 2018 when we were struggling to understand how we would be able to implement a QMS in the company. We had the very naïve idea that we would build one from scratch! One conversation with Richard later we realised that we needed serious help. Now in 2021 we have a fully functional QMS and robust technical file for our first product. What has been so good about working with Richard is that the support doesn’t end after the initial installation of the QMS. The support and advice continues whenever you need it and best of all no question is too stupid for him to answer. Without Richard’s support we’d still be floundering around wondering how to get started. I would highly recommend Richard to anyone in the IVD/MD space."
James Burnstone, Pill Connect
"As a small start up, getting the installation and management of a 13485 QMS right was a daunting prospect. Fortunately, we found Richard who over a short period got us up and running with a simple yet robust QMS matched to our current needs. Richard provided training over Zoom which was insightful and helped navigate both the QMS and the medical device regulatory pathways. Throughout this Richard has been a pleasure to work with and I would highly recommend him."
LRQA Stage II 13485 Audit report
"The functioning of the QMS is considered in no small way to have supported the organisation’s success in its two years of existence. The primary goal of achieving customer satisfaction to secure repeat business is underpinned by a commitment by the staff to a system that works for them. The structure and organisation of the QMS has no doubt assisted the small team in achieving a lot in a relatively short space of time."
Ian Mawhinney, ASep Healthcare
"Richard’s system is installed and in use at ASep for the past 5 years. It is working very well, and is relatively easy for us to manage.
The best thing is that the system is tailored to our minimum requirements so that it doesn’t generate additional work unnecessarily.
We run it, it doesn’t run us."
Patrick Hall, Designing Science
"I work extensively with university-based start-ups and SMEs entering the medical device market for the first time. Richard has been a valuable partner in helping my clients to understand the regulatory process and what it means for their project. I believe his approach, an adaptable template TF and QMS is a valuable tool in helping aspiring medical device companies get to grips with regulatory affairs quickly and economically."
John Hall, Albert Waeschle
"Thanks for the training this week, we all found it very informative and can now see what a massive positive impact this standard will make to our business. Importantly I think it will bring a much needed change in mentality and culture."
Contact us today to see how we might help you!.