Consultancy
We offer help for ISO 13485, medical devices and in-vitro diagnostic medical devices.
Whether an idea, finished product or somewhere in-between, we help with compliance to MDD and IVDD and transition to the new regulations MDR and IVDR and on-going support for your company and products.
We cover other Standards such as ISO 9001, ISO 14001 and ISO 45001.
Q-Share
‘Q-Share’ - Quality and Regulatory Support
Once you have your Quality Management System or Product Certification it is mandatory you review the information and keep it up to date.
This is where our ‘Q-Share’ can help as we can be part of your resource, adding over 20 years experience just by emailing, calling or face to face conversations.
We can also act as your ‘Authorised Representative’ and ‘Person Responsible for Regulatory Compliance’ in both the UK and EU-27 as required by both the MDD, IVDD, MDR and IVDR.
CE Marking and UK Conformity Assessment (UKCA)
We have been acting as CE Authorised Representative for over 15 years for a number of manufacturers of both medical devices and in-vitro diagnostic medical devices.
To save you time this is a bullet point list of services we offer for CE and UKCA Marking.
Authorised Representative Services
Person Responsible for Regulatory Compliance
Importer
Details of CE Requirements can be found here and UKCA Requirements here.