Audit Evidence Pack Template
An Audit Evidence Pack is a structured collection of documents, records, and technical artefacts that demonstrates your product's compliance with a given regulation. For the Cyber-Resilience Act (CRA), this pack constitutes the technical documentation that manufacturers are legally required to maintain and provide to market surveillance authorities upon request (CRA Art. 31).
CRA 5-Minute Primer
The EU Cyber-Resilience Act (CRA) is a landmark law that makes cybersecurity a mandatory, legal requirement for all "products with digital elements" sold in the European Union. For the first time, secure-by-design principles are moving from best practice to a legal obligation, enforced through CE marking.
CRA Gap Analysis Checklist
A Gap Analysis is a critical first step in your journey to compliance with the Cyber-Resilience Act (CRA). It helps you identify the differences ("gaps") between your current security practices and the legal requirements of the regulation.
Cyber-Resilience Act (CRA)
1. Why the CRA matters now
FDA Cybersecurity
1. Why FDA Cybersecurity Requirements Matter
First-Sprint Checklist
Getting started with a large compliance framework like the Cyber-Resilience Act (CRA) can be daunting. This checklist is designed to be a practical, actionable guide for development teams and product managers. It breaks down the initial work into concrete tasks that can be planned into your first few agile sprints.
In Vitro Diagnostic Regulation (IVDR)
1. Why the IVDR matters for connected devices
Medical Device Regulation (MDR)
1. Why the MDR matters for connected devices
NIS 2 Directive
1. Why NIS 2 matters now
PECR (UK)
1. Why PECR matters for Connected Devices
PSTI Act (UK)
1. Why PSTI matters now
Radio Equipment Directive (RED)
1. Why the RED cyber rules matter now
Secure-by-Design Maturity Model
A maturity model is a tool that helps an organization measure the effectiveness and completeness of its practices against a defined standard. This Secure-by-Design (SbD) maturity model is designed to help you assess your product security capabilities, identify gaps, and build a roadmap for continuous improvement.
User Information & Documentation
1. Introduction to User Documentation