Regulatory Submissions
We have a long-lasting relationship with our customers in the IVD industry and beyond, and we are incredibly proud of how we have helped companies of every size navigate the complexities of IVD regulations
Supporting You
Educate
Help you understand the regulations
Evaluate
Portfolio assessment & planning
Execute
Achieving your compliance goals
Sustain
Keep on top of regulatory changes
How we can help
We always strive to make the services we offer as easy to understand as possible, as a result we have come up with some common services that we can offer to support you. Our aim to support you and your organisations journey in the design, development, placement on market and distribution of in-vitro diagnostic medical devices.
We use our network and regulatory surveillance tools to keep our customers informed of relevant regulatory updates, and help you to understand the implications of these changes to product profiles.
Global Registrations
UKCA Marking
EU CE Marking (IVDR)
FDA 510(k), PMA
Case Studies of Customers we have Supported
Early Stage European Start-up
From the early beginnings, we gave a start-up some basic training on what regulations are applicable to their potential device. We talked through regulatory strategies and pathways, working out the best route forward. We helped them achieve UK registration of their diagnostic device.
Multi-national IVD Manufacturer
The manufacturer had a large regulatory team, but needed specific expertise to help develop and write technical & clinical performance reports to support their IVDR submission. We worked with their regulatory and clinical teams to deliver plans and reports as required by the European IVD regulation.
Mid-size UK IVD Manufacturer and distributor
This company had a small but experienced regulatory team, however they identified that there was so much changing with the regulations in the EU and UK, they needed some support to monitor the IVD regulatory landscape, and call on some external regulatory experts to talk through their ideas and understanding of any new updates. We continue to support this company with periodic calls to discuss upcoming regulatory challenges and opportunities.