Support and guidance for regulatory compliance
We are fully certified to ISO 13485:2016 by LRQA but don’t profess to be experts in all regulatory requirements, compliance and quality management systems etc. Therefore, we have a number of pre-approved associate consultants who are experts in the medical device regulations for Europe and the US. They provide up to date advice and guidance to HD for MDR and FDA requirements. For those clients which require it, our consultants can work directly to deal with your project’s regulatory requirements too. Having this safety net is invaluable as it allows us to concentrate on design and development. Using this approach means our regulatory consultants ensure we, and if it helps, our clients work to the latest standards and best practices throughout a project.
If you are encountering difficulties, need expertise, resource or have a problem to solve then please give us a call, we will always try to help.