Mitigating Risks for Medtech & Pharmaceutical device Manufacturers
The FDA believes this is a good time to reinforce the importance of medical device cybersecurity and the role we all play in medical device 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. The healthcare industry is now a major target for cybercriminals, potentially compromising data and placing the safety and health of patients at risk. Strengthening the security of connected medical devices against cyberattacks is more important than ever. Today’s medical device user demands proactive security. Syncro Medical is certified with applicable ISO 27001 requirements; we include security checkpoints at all stages of development. The NIST Cyber Security Framework has identified five key functions that medical device developers and manufacturers should consider when planning their cybersecurity strategy. We consider this framework throughout the development process.
The FDA 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.
Develop the organizational understanding to identify and manage cyber security risks to systems, assets and data.
Develop and implement the appropriate safeguards to ensure delivery of essential services, and to limit or contain the impact of a potential cyberattack.
Develop and implement the appropriate activities to identify the occurrence of a cybersecurity event.
Develop and implement the appropriate activities to take action in connection with a detected cybersecurity event.
Develop and implement the activities to maintain plans for resilience and to restore any capabilities that were impaired due to a cybersecurity event.