Achieve medical device regulatory approval for UKCA & CE-marking.
- Technical File Production
- Clinical Evaluation
- Systematic Literature Reviews
- Risk Management
- Clinical Strategy Development
- PMS & PMCF
- Further MDR Services
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That's OK, we are experts and can provide systematic help, support and organisation for your circumstances. This monthly model is ideal for access to experts to guide you. Just starting is good, but starting in the correct order with an expert-backed plan is better!
That's fine. This can be a very efficient way of working. Just tell us what you have and we can start work in the background while you finalise what you need to.
Of course! We work on everything from re-engineering resubmissions, starting new submissions, through to continued recertification support.
No problem. Tell us what you require and we'll provide an estimated time frame so you only pay for what you need. If you decide you require more support then we can work on tasks in tandem or parallel. The monthly contract can roll for as long as you need expertise or guidance with other aspects of your submission.
We have the expertise and capacity to help get your device to market whatever your circumstances. Please contact us to discuss your personal requirements.
We cover everything you need for your medical device approvals
Achieve medical device regulatory approval for UKCA & CE-marking.
Ensure Notified Body acceptance through expert in vitro diagnostic device regulatory consulting.
We are your partner to full approval, solving regulatory challenges through tailored routes to compliance
All-inclusive consulting from £2,850 per month - your first week is free!
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