We understand you have a business to run so at Compliance Solutions (Life Sciences) we balance that priority with delivering the regulatory requirements that your business needs to be compliant.
Whether navigating the FDA processes, obtaining CE marks or acting as your EU or UK Authorised Representative, Compliance Solutions will take you through the process in a way that minimises time and resources – while meeting all the requirements of such standards.
Our hands-on practical approach is based on years of working with a vast range of different types and sizes of companies in the medical device industry, meaning you get the best advice and clearly identified actions which lead to successful approval of your products.
COMPLIANCE (n): conforming to a rule, specification, policy, standard or law.
SOLUTION (n): the act of solving a problem, question, etc.
Their responsiveness and attention to detail on even the smallest of matters, allied to their diverse range of expertise, are why we at Vascular Flow Technologies put our complete trust in the team at Compliance Solutions.Craig Dunlop – General Manager
CS 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
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.Forbes Butterfield – Product, Marketing and Development Director
Edwin is a gem of a consultant and friend to GyroGear. He came highly recommended via the EC Horizon 2020 programme and has worked tirelessly ever since. We could not be more grateful for expertise, support and breadth and depth of knowledge.Faii Ong – Founder and CEO
- Expertise in Medical Devices and IVDs
- Proficiency in Biological, Blood Establishment & Stem Cells industries
- Straightforward and successful regulatory routes to market
- CE, FDA, PMA, Pre IDE, IDE, NICE, MHRA experience
- International regulatory submissions
- A hands-on approach to achieving approvals
- QMS Implementation/Maintenance
Compliance Solutions understand that your business will often have a varying requirement for consultancy support to meet the fluctuating needs of particular projects and activities.
That’s why we provide you with a flexible approach that is entirely tailored to your specific requirements.
Compliance Solutions (Life Sciences) Ltd has many years of experience within the life science industry (including blood establishments) advising on how to best meet the regulatory requirements of the MHRA, FDA, Notified Bodies and ICH, for the one-man start up to multi-national companies.
As the situation regarding COVID-19 continues to develop, Compliance Solutions have answered the call for assistance from technology companies…