From business decision-making and system building to secure development, vulnerability management, and product selection.
Information and solutions necessary for CRA compliance.
We will introduce solutions tailored to the stage of your challenges.
Issue
In CRA (Clinical Research Assurance) implementation, the challenges vary depending on one's position, ranging from management decisions and organizational structure to development processes and product selection.
About
Cyber Resilience Act
(CRA) is
This EU regulation requires security measures throughout the entire product lifecycle for digital products sold in the European market.
The target companies are required to address not only product development but also the following areas:
CRA support is already
From the preparation stage to the execution stage
The mandatory reporting of exploited vulnerabilities and critical incidents came into effect on September 11, 2026.
Failure to report or violation of regulations may result in administrative action or fines.
CRA (Clinical Research Abuse) response is finally moving from the "preparation stage" to the "implementation stage."
01
The reporting obligation will apply from September 11, 2026.
Manufacturers are required to follow prescribed reporting procedures regarding exploited vulnerabilities and serious incidents that affect product security.
02
Prepare now in anticipation of the start of application of key obligations.
With the major mandates coming into effect in December 2027, it will be necessary to integrate security into the development process. Multiple departments, including quality assurance and product planning, will need to collaborate and address this on a product-by-product basis.
03
Consider the entire product lifecycle.
Our services cover requirements definition, design, implementation and testing, production and shipping, and post-release management.
Complying with CRA (Clinical Research Assurance) requirements is not complete simply by knowing the relevant laws and regulations.
The first step is to clarify what stage your company is at and what preparations you need to make.
Solution
When dealing with CRA (Clinical Research Assurance) requirements, the scope of work changes, encompassing everything from information gathering and system building to technology implementation and operation.
Macnica offers solutions across more than 20 different products, proposing the optimal choice tailored to each customer's specific needs, rather than focusing on a single product.
For companies unsure how to proceed with CRA (Clinical Research Assessment), we provide support for current situation analysis, gap analysis, and policy formulation. We don't just stop at identifying issues; we provide comprehensive support all the way through to the subsequent technical implementation.
This service supports the establishment and operation of product security activities.
It visualizes software configuration information and supports the software management required for CRA (Clinical Research Ability) compliance.
We continuously collect, analyze, and prioritize detected vulnerabilities.
We provide the foundation that supports product authenticity and secure communication.
We support the implementation of security features necessary for CRA compliance. We can offer solutions in both software and hardware aspects, from authentication infrastructure and SBOM to vulnerability management and secure semiconductors.
You can obtain necessary parts and product information during the evaluation and prototyping phases.
From management and organizational structure to development processes and product selection.
From identifying the issues to developing specific solutions, Macnica will support you every step of the way.
