Navigating Cybersecurity Compliance: A Lifecycle Approach for Medical Device Manufacturers
Objective
This whitepaper outlines the medical device software lifecycle processes and details the necessary documentation and activities required to meet new cybersecurity requirements. We will cover best practices for integrating cybersecurity throughout the medical device lifecycle, from design to post-market management. Key global regulatory expectations from the FDA and EU will be highlighted, along with insights into common challenges that result in approval rejections. Additionally, the document will include examples of regulatory body responses and real-world feedback from the past year, guiding manufacturers toward improved compliance and enhanced product security.
Medcrypt
Medcrypt, Inc. is a San Diego-based cybersecurity provider for the healthcare industry, specializing in Software Bill of Materials (SBOM) and risk management solutions. By offering cutting-edge encryption, vulnerability analysis, and monitoring services, Medcrypt empowers medical device manufacturers to secure their products throughout the device lifecycle.
For more information
website: www.medcrypt.com
email: [email protected]
Johner Institute
Johner Institute provides services for the medical device regulations in different international markets. They establish, audit, and improve quality management systems. They review or create technical files including risk management, usability engineering, software life cycle, security life cycle, physical and biological safety, labeling and clinical evaluation. They also offer services for regulatory monitoring and post-market surveillance.
For more information
website: https://www.johner-institute.com/
email: [email protected]
Download '.pdf' Format of the whitepaper.
