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 whom are experts at understanding the Medical Device Directive, and working with the MHRA or FDA for submissions and regulatory compliance. They provide up to date advice and guidance to HD and also directly to our clients for applicable regulatory requirements when required too. Having this safety net is invaluable as it allows us to concentrate on design and development, whilst our consultants ensure we 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.