Capturing the evidence you need for device registration
With Camgenium you can collect trial data from early in development and even integrate the trial management system into your product.
Applications for medical device certification must be supported by appropriate evidence. But trials are often time consuming, normally take place after completion of the device development and require specialist skills and data collection systems.
At Camgenium, we aim to shift real-world testing of different aspects of the product as early as possible in the development process so that they run concurrently with other development activities to minimise the overall project timeframe. This has obvious advantages, not least that any issues found can be addressed early and at least cost. In particular, we aim to verify technical capabilities of a product as early as possible. This could be evidencing the sensitivity, repeatability, precision and accuracy of a sensor. Or it could involve using new datasets to check Artificial Intelligence and Machine Learning algorithms against independent references.
We also aim to bring forward testing of user interfaces and use mechanisms to ensure that users will be able to use a product effectively and safely, and to ensure that any accessibility issues have been addressed. Testing user interfaces and use mechanisms also allows sensitive cost – benefit data to be collected that will allow health economics analyses to be undertaken to support claims about benefits and allow clients to develop sophisticated commercial models and support pricing agreements.
The format of the testing will be informed by the medical device Class of the product.
A final trial will validate the product as used by the intended population against its claims and intended functionality and will also provide final safety and efficacy data. The data it generates play a pivotal role in securing regulatory approves, and it should be the last step in generating the data needed to support a submission for device certification.
The Camgenium platform allows any product built using it to extend websites and produce apps to form a system that will manage clinical trials and capture all data they generate. The platform is compliant with Good Clinical Practice (GCP), the clinical trials standard. It can be used to quickly and easily produce trial management systems that also meet the data security and privacy requirements of the General Data Protection Regulation (European Union) and HIPAA and HITECH (United States).
The team at Camgenium has experience of setting up and running clinical trials and can provide support to clients to help with all aspects of running a trial, including writing the protocols, submissions to ethics committees and on-going monitoring and reporting.
