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