Capturing the evidence you need

To submit your product for medical device registration, you need to evidence that it is safe and that it meets the sales claims.

Image shows elderly gentleman using an app that automatically captures biomarker information from connected devices and other data entry methods. At the same time, a researcher is reviewing trial data on a screen. — Camgenium undertook a major NHS trial to investigate the possibility of using connected devices with AI data analysis to provide early identification of deterioration and prevent hospital admission. We successfully supported a cohort of about 600 NHS patients aged from 65 to 93 with over 90% compliance to the study protocol.

To evidence that your product is safe, you need risk assessments that identify all the possible ways in which it could cause harm and devise tests for them. Likewise, each of the sales claims must be tested.

We aim to undertake these tests as early in the prototyping phase as possible in case the results show that there is a problem that must be addressed. This also means that the outcome of the final product validation testing should be assured, can be rapidly completed and your product can be submitted for registration as a certified medical device.

Risk assessments

Test prototypes

Sometimes, the only way to test whether a product will be safe or meet a sales claim is to create a prototype that allows one aspect of safety or one claim to be tested. This could be a prototype that allows a sensor to be fully characterised. We build specific prototypes that meet full medical device and GCP standards and ensure that all data generated is captured in the required format for your final technical file. Again, we aim to do this testing as early as possible in the prototyping phase

Data capture

Clinical trial management system

We can even build a full clinical trial management system as part of the backend of your product to allow you to run extensive and sophisticated trials to full GCP requirements. This is particularly useful for final product validation when you confirm that your product meets all of the sales claims and any other requirements of the jurisdiction where you will sell it, such as NHS DTAC in the UK.

Planning and running a clinical trial

Read more about how we can help you with trials.

Find out more

Next stage: Deployment and operations