Cybersecurity for Network Connected Software and Devices

All medical devices carry a certain amount of benefit and risk.
The International Authorities, like FDA, allows devices to be marketed when there is a reasonable assurance that the benefits to patients outweigh the risks.
Traditional medical devices are increasingly connected to the Internet, hospital networks, and to other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients, and stand-alone software used in the clinical field or the Medical App are increasingly available.
These same features also increase the risk of potential cybersecurity threats, Medical devices, like other medical computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.
The manufacturer shall properly manage these cybersecurity threats to put its device on the market. The cybersecurity threats shall be managed since from design phase of the device.
Maytal, through the experience gained in over 10 years of work in medical software, is able to help the company through:
  • Cybersecurity documentation preparation as required by FDA for the “510(k) submissions” or for the “Additional Information (AI) responses
  • Cybersecurity assessments audits, on the already developed software, to verify level of compliance to FDA guidance, as well as for cybersecurity requirements in other global markets.
  • Participate at the design process, together with the software developer, to help the identification of the vulnerabilities and weaknesses early in the design process.
  • Train employees of the company in the design of safe products for cybersecurity.
  • Prepare risk documentation related to cybersecurity and FDA cybersecurity guidance