In medical devices, risk management is expected to be an ongoing activity, which is considered, controlled and documented across all phases in the life of a product, from the initial conception to development and testing, market authorization, post-market use, and through to end-of-life and retirement.
When cybersecurity risk is not effectively managed throughout the life of the device, it can lead to issues including a medical device failing to deliver its therapeutic benefit, a breach in the confidentiality, integrity, and availability of medical device data, or malicious unauthorized access to the medical device and the network it operates on.
We can assist in establishing enterprise-wide processes to manage medical device cybersecurity, creating design features that enable postmarket management of security risk, and implementing processes to manage device security patching.
We have the regulatory savvy, QMS experience, and technical expertise to help mature and emerging technologies companies meet their challenges and take full advantage of their business opportunities.
Files coming soon.