Mitigating Risks for Medical Device Manufacturers & Digital Health Products

Developing secure and cybersecurity-resilient medical devices is of paramount importance, given the sensitive nature of patient data and the potential impact on patient safety. Advances in technology have enabled medical device manufacturers to develop more efficient and effective products. However, along with these advancements have come a new set of challenges for patients, providers, device developers and manufacturers.

Syncro Medical is certified with applicable ISO 27001 requirements; we include security checkpoints at all stages of development.

The FDA, EU MDR and global regulators are working to implement rigorous requirements intended to strengthen the cybersecurity of medical devices. Regulators mandate security that is “baked in”. At Syncro Medical, cyberthreat mitigation measures are indeed baked into the software development process from the earliest stages of requirements definition and product design. We’re also available to help with cybersecurity implementation for medical products already on the market.