White Paper

Navigating Emerging Standards and Regulations: A Guide for Medical Device Manufacturers

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.

What you will learn

  • Key FDA guidance documents and regulations
  • Preparket considerations and the required content of premarket submissions
  • Postmarket considerations for managing ongoing cybersecurity risks
  • European Union (EU) Medical Device Regulation expanded scope
  • International standards & frameworks like IEC 62443, IEC 62304, ISO 14971 and others
  • Key steps for compliance preparation - a complete guide

Read now

Free White Paper

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.