This white paper aims to provide a complete understanding of the emerging standards and regulations that govern medical device cybersecurity. We will delve into key guidelines and regulations issued by the U.S. Food and Drug Administration (FDA), the European Union’s Medical Device Regulation (MDR), and international standards such as IEC 62443, ISO 14971, and UL 2900-2-1. Furthermore, this paper will outline the steps MDMs need to take to prepare for compliance.
As the healthcare industry embraces the benefits of interconnected medical devices,
ensuring cybersecurity and compliance becomes paramount. MDMs must understand
and adhere to emerging standards and regulations to protect patient safety, maintain
market access, and safeguard their reputation. Compliance is not just a regulatory
requirement; it is a fundamental step toward building trust in the industry. Learn how to approach it with our free guide.