Service - Medical Devices Archives

FDA 510(k) Update for MedTech: What Businesses Need to Know in 2025

14 August 2025

Robert Wilson

FDA 510(k) update guidance has introduced new expectations around cybersecurity for medical devices, reshaping how manufacturers must approach compliance, documentation and ongoing support. This update matters not just to regulatory teams, but also to businesses navigating digital transformation. With medical technologies becoming more interconnected, the security of these devices is now a key factor in ... Read more

MedTech Cyber Security

17 July 2025

Robert Wilson

As healthcare technology evolves, medtech cyber security has become critical. From regulatory compliance to patient safety, the stakes are high. At Amicis Group, we help medical device manufacturers secure their products, meet international standards and build trust with healthcare partners and regulators alike. In this article we discuss the issues around protecting medical devices, ways of ... Read more

Navigating FDA 510(k) Submissions – Cybersecurity Controls for Medical Devices

2 September 2024

Robert Wilson

To support standards in cyber security for medical devices, the U.S. Food and Drug Administration (FDA) has established rigorous requirements as part of its 510 (k) pre-market submission process. The medical device industry is evolving rapidly, with new innovations transforming patient care and treatment. However, as these devices become increasingly connected and reliant on software, ... Read more

Service - Medical Devices

FDA 510(k) Update for MedTech: What Businesses Need to Know in 2025

MedTech Cyber Security

Navigating FDA 510(k) Submissions – Cybersecurity Controls for Medical Devices

Ready to get started?