Medical Device Security

Comprehensive Security Solutions for the Medical Device Industry

We help our clients design and build medical devices to resist cyber attacks and to prevent access to the vital networks healthcare organizations operate

Chalir’s  team of cybersecurity experts, which includes some of the industry’s most recognized authorities, provides guidance to ensure device manufacturers meet  complex regulations imposed by the FDA and other regulatory bodies throughout the world

We work with you to understand your risks and assess your software and hardware so you can submit robust, third-party expert evidence, demonstrating the safety and security of your medical device or ecosystem and achieve Premarket Approval.

Premarket Submission / Regulations Requirements

We provide the comprehensive reports and documentation of the security measures, tests, and validations performed, suitable for submission to regulatory bodies like FDA

Post-Market Surveillance & Regulation Requirements

Leverage our expertise in security, compliance and cybersecurity monitoring to help you meet PMS obligations.

Advanced Medical Device Security Services

Enhance device security for sensitive applications, protect your valuable intellectual property, and ensure the integrity of your selected components with the help of our experts.