About Adaptiv Risk

Adaptiv Risk was created to help medical device manufacturers bring safer devices to market faster and cheaper through the use of a fully integrated SaaS platform that handles all aspects of cybersecurity risk management. The seed for Adaptiv Risk was planted in early 2022 when it became increasingly clear that the FDA was going to finally issue non-draft guidance on cybersecurity and put some teeth behind the regulations. This new guidance, which was issued in 2023, puts new filing conditions in place that medical device manufacturers must meet in order to have a successful 510(K) or PMA submission. The Adaptiv Risk platform is designed to reduce the compliance burden and therefore allow device manufacturers focus on innovation and not paperwork.

The name Adaptiv Risk is a play on the adaptive risk management methodology. Essentially, adaptive risk management is a method for identifying, evaluating, and reducing risks in a dynamic environment. Cybersecurity is one of the most dynamic environments around given the near constant change that occurs. The Adaptiv Risk platform helps keep you informed of existing risks while quickly identifying new risks so you are not caught off-guard.

The chameleon found throughout the site represents an animal that is synonymous with adaptability. By being able to blend in with its environment, a chameleon can reduce its own personal risk when necessary while also standing out when beneficial.