Description

The Medical Device Cybersecurity Documentation Kit is a ready-to-use package designed to help manufacturers and consultants ensure compliance with the growing regulatory requirements for medical device cybersecurity. With increasing scrutiny from the EU MDR, FDA, and global regulators, this toolkit provides all the essential policies, procedures, templates, and forms needed to manage cybersecurity risks throughout the medical device lifecycle.

Whether you are preparing your Technical Documentation (Annex II & III), addressing FDA premarket cybersecurity requirements, or strengthening your ISO 13485 QMS integration, this kit gives you a structured framework to demonstrate compliance, safeguard patient safety, and satisfy auditors and Notified Bodies.

What’s Included:

• Cybersecurity risk management procedure aligned with ISO/IEC 14971 and AAMI TIR57

• Threat modeling and vulnerability assessment templates

• Secure software development and patch management procedures

• Incident response and post-market surveillance forms

• Checklists for FDA cybersecurity premarket submissions and EU MDR technical documentation

• Guidance notes to support customization and practical implementation

Key Benefits:

• Time-saving: Ready-made, audit-ready templates save months of preparation.

• Comprehensive: Covers both premarket and post-market cybersecurity requirements.

• Compliant: Aligned with FDA guidance, EU MDR, MDCG documents, ISO/IEC 81001-5-1, and industry best practices.

• Customizable: Fully editable Word/Excel templates to adapt to your device and processes.

Who Should Use It:

• Medical device manufacturers preparing for EU MDR or FDA submissions

• Startups and SMEs developing connected or software-driven medical devices

• Consultants supporting clients in cybersecurity and regulatory compliance

• Companies enhancing their QMS with cybersecurity-specific documentation

With the Medical Device Cybersecurity Documentation Kit, you gain a proven set of tools to build trust, ensure regulatory compliance, and protect patients by addressing cybersecurity risks effectively.

What’s included:

The list of documents included in the Medical Device Cybersecurity Documentation Kit is reported below: