July 18, 2024
The medical technology landscape is rapidly evolving, enhancing patient care and outcomes. However, this advancement brings cybersecurity challenges as devices become more connected. Recognising this, the FDA has introduced new regulations to bolster cybersecurity in medical devices. These regulations emphasise integrating cybersecurity throughout the device lifecycle, from premarket submission (510K) to post-market surveillance, including heightened measures such as threat modelling, SBOM, and cryptography.
The FDA's enhanced scrutiny during the 510K process requires manufacturers to include a comprehensive cybersecurity risk management plan. This plan should detail potential threats and mitigation strategies.
Manufacturers must actively monitor and manage cybersecurity risks, ensuring continuous device safety and performance through regular updates and patches.
Navigating FDA regulations can be daunting. Sectech Solutions offers cybersecurity risk assessments, regulatory compliance support, post-market surveillance, and incident response services to help manufacturers meet these requirements. They also provide training programmes to equip teams with cybersecurity knowledge and skills.
The FDA's new regulations highlight the importance of cybersecurity in medical devices. Ensuring compliance is crucial for patient safety and trust. Sectech Solutions supports manufacturers in meeting these challenges, helping bring secure and innovative devices to market. Partnering with Sectech Solutions ensures your devices meet the highest safety and security standards.
