A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.
The prescription-only diagnostic allows patients to self-collect saliva samples to test for SARS-CoV-2.
Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.
Without even factoring in the effects of COVID-19, ransomware attacks against healthcare providers have significantly increased. We must be ready to detect and respond to them before damage can be done.
COVID-19 requires us to rethink our current device disinfection procedure.
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
Artificial intelligence and machine learning are proving to be meaningful weapons in our arsenal during the coronavirus crisis.
Vulnerability sharing arms stakeholders with the information they need to assess devices, minimize cybersecurity risks and proactively mitigate emerging risks to prevent exploitation.
Make sure your 510(k) submissions pass with flying colors. Explore the latest regulations impacting bacterial endotoxin testing.
It is the first federal approval for a test that uses saliva as the primary test biomaterial for COVID-19.