Axis was very pleased with the help, advice and support Compliance Solutions provided with the company’s first 510(k) submission. The process went very smoothly and the 510(k) was received on schedule – if not early.
Axis will continue to work with Compliance Solutions and would recommend the services and skills of the team they have.
Jon Arcos – CEO & Founder
The Compliance Solutions team provides day to day support to our quality and regulatory functions.
They have a can-do attitude and look at everything from a holistic approach – and ensure compliance without losing sight of the needs of the business.
Their team has a wealth of expertise that is helping us drive forward the quality and success of Brightwake.
Stephen Cotton – CEO
The idea of establishing a quality management system for ISO 13485 was a daunting task for us. We knew we had to have this in place for our medical device company but we didn’t really know where to begin or what questions to ask.
We were introduced to Compliance Solutions by a partner company of ours and we haven’t looked back since. Edwin and his team took us through the whole process and trained us how to use and maintain our QMS.
We gained ISO 13485 certification within 7 months of starting the process and have successfully maintained the system through annual surveillance and re-certification audits for the last 5 years. They have also helped us to establish a storage and distribution system for the US and the EU so that we have a supply chain that meets all the regulatory requirements.
Compliance Solutions have been with us every step of the way and have continued to guide us through the many faceted regulatory processes of the EU and FDA. Edwin and his team have a professional and pragmatic approach to regulatory matters which they deliver to great effect. We will continue to use their services and I have no hesitation in recommending them.
John Foord – Operations Manager
Compliance Solutions worked with us from the start, they guided us through setting up contract manufacture, ISO13485 certification, CE marking of our remote patient monitoring device.
They worked tirelessly with us to navigate the 510K process in the USA and ultimately led us to clearance for our remote monitoring device.
Their expertise in understanding and delivering FDA’s complex software requirements was invaluable.
Christopher McCann – CEO and Co-Founder
Compliance Solutions has been working with G+N Medical for more than a decade, initially helping us to become ISO 13485 & ISO 9001 accredited.
Since then Compliance Solutions has been at the heart of our organisation, assisting us through regulatory changes, transitions and more recently working with us to become MDR compliant.
The team are amazing, providing insightful industry knowledge whilst also knowing how to apply it within an organisation, creating buy-in from all departments and making the process as stress free and easy as possible.
It’s a pleasure to work with them and we know our business is in safe hands.
Emma Simpson – CFO
Edwin is a gem of a consultant and friend to GyroGear. He came highly recommended to the company via the European Commission Horizon 2020 grant programme.
Edwin has been working tirelessly with us ever since, and we simply could not be more grateful for expertise, support and breadth and depth of knowledge.
Having a knowledgeable regulatory partner is key helping small businesses like ours navigate the EU and US markets, which is unfortunately daunting.
Being at the other end of the line on a weekend often makes things happen that much quicker!
Faii Ong – Founder and CEO
Compliance Solutions was engaged to provide cover for our Quality Manager post. The company supplied a part-time Quality Assistance Manager (Suzanne Slater) and a variety of supplementary services (audit support, document review) to the Centre for Diagnostic Development in Edinburgh for almost a year.
The service provided was good throughout, and the team at Compliance Solutions were able to fill the post, work with the LifeArc team, advise on best practice and streamline some of our more time consuming processes.
Craig Thomson – Project Manager, Centre for Diagnostics Development
Edwin Lindsay of Compliance Solutions has served as our EU-Authorized Representative for many years now.
He provides the needed expertise in EU Regulations along with a vast array of experience in medical device regulation and Quality Systems.
He is our “go-to” resource for our International Regulatory Compliance and we would highly recommend him.
Barry Camrell – Vice President, QA/RA
We have used Edwin and his team for over 10 years. They always provide the right advice to keep you compliant and their pragmatic approach ensures you can get on with the job of running the business, without having to worry about the regulatory issues.
Sometimes it may not be what you want to hear, but with Edwin, you always get the facts. I have recommended Edwin to a few friends in the MedTech Industry and everyone has been grateful for Edwin’s help.
More than ever, in these challenging and changing times you should look no further than Edwin and the CS team.
Forbes Butterfield – Product, Marketing and Development Director
Edwin has supported Touch Bionics for over 10 years and has an excellent knowledge of the regulatory requirements for medical products at all class levels.
Edwin supports higher level strategies for medical products and has in depth awareness of the entire process, with practical knowledge of the implementation of ISO13485 for both Manufacturing and Research and Development and EN testing standards.
I would highly recommended Edwin for any support for compliance for medical products.
Hugh Gill – VP of R&D
