Ensuring compliance through deployment
Medical device regulation requires surveillance and monitoring of all deployed products. This requires a team with specialist skills and data collection / reporting systems that are fully auditable.
Camgenium can take legal responsibility for the regulated requirement that manufacturers face to ensure their device meets appropriate standards of safety and performance for as long as it is in use.
At a minimum during deployment, all appropriate KPIs must be monitored and full data captured on any adverse events associated with the product and reported to the appropriate authorities. This requires a team with specialist skills and fully auditable systems for data collection and reporting. By transferring the responsibility for this requirement to Camgenium, manufacturers eliminate significant cost, risk and management burden.
On-going monitoring provides information about device performance, in particular patient safety and device usability and enables user feedback to be logged, collated, responded to and acted on by making necessary improvements. We can take responsibility for ensuring that the device is meeting appropriate standards of safety and performance in use. We also provide a method to capture adverse incidents and ensure that they are reported to the appropriate authority if needed. We also ensure that vulnerability to intentional and unintentional security threats is continuously monitored as part of this surveillance work.
We plan surveillance and monitoring activities before launch and set up automated data collection and reporting.
Corrective actions may be required when a process is not correctly followed or a product does not meet its specified requirements (i.e. is nonconforming). In the first instance, we contain it to prevent unintended use or delivery. We analyse the problem and its root cause and take action to eliminate the nonconformity and identify and eliminate its cause so that it cannot recur in the future. If necessary, the Camgenium platform can erase apps built on it and associated data from end-user devices.
Product decommissioning is an important activity that should be planned as part of the product realisation. End-of-life activities should ensure that product maintenance, support and distribution are terminated gracefully in a controlled way to minimise impact to patient safety and public health.
Key issues include deactivation and removal of software and data, and there may be country specific issues regarding how data is managed.
Patient data must be properly safeguarded and archived in accordance with local legislation. In the case of a software medical device, this could include migrating patients to another product. Patients and other end-users must be informed which services will be available once the end-of-life is signed off, and sufficient lead times must be provided. At all times the security and integrity of information and systems must be ensured.
