On-demand seminar

CRA compatible,
How to proceed
Best practices.

Macnica CRA Conference 2026

Moving on from "What to do?"
With Macnica 's total solutions,
One month to decide on the approach.

Register for the on-demand seminar (free).

What I need
Content only
You can watch it!

Registration is open from November 2nd (Mon) to November 30th (Mon), 2026. After registration, you can view the content anytime during the event period.
Hero visual image for the CRA On-Demand Seminar.

Issue

Are you experiencing any of these problems with CRA (Clinical Research Associate) support?

CRA (Clinical Research Assurance) solutions involve a wide range of issues that need to be addressed, from management decisions and organizational structure to development processes and product selection.

An image illustrating the idea of "not being aware of the latest trends in CRAs (Clinical Research Associates)."

I am not aware of the latest developments in CRA.

  • I don't know where to find the latest information.
  • We are unable to understand the impact that the latest trends in standards will have on our company.
  • I don't know how to proceed with preparing for future actions.
An image illustrating the situation where "the company-wide response system and procedures cannot be decided."

We are unable to decide on a company-wide response system or procedure.

  • The division of roles between departments has not been decided.
  • I don't know how to create company-wide rules or reporting systems.
  • Unable to determine the methods and tools that are right for our company
An image illustrating the inability to "build a development process that can accommodate CRAs (Clinical Research Associates)."

We cannot build a development process that can accommodate CRAs.

  • There is a shortage of expertise and personnel in secure development and vulnerability management.
  • I don't know the difference between the standards we already comply with and the CRA.
  • I don't know how to proceed with threat analysis and requirements definition.
An image illustrating the inability to translate CRA requirements into actual product design.

CRA requirements cannot be translated into actual product design.

  • Interpreting the results of threat analysis and requirements definition is difficult.
  • It is not possible to determine compatibility with current specifications or ease of implementation.
  • Unable to select software and hardware suitable for the requirements

For those who fit even one of the following criteria

This on-demand guide will explain the overall picture of CRA (Clinical Research Associate) compliance and the key points you need to know!

Register for the on-demand seminar (free).

About

What is a CRA?

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:

  • Vulnerability management
  • SBOM management
  • Secure development
  • Incident Report
  • Post-shipment operation

CRA support is already
From the preparation stage to the execution stage

It was misused from September 11, 2026.
The obligation to report vulnerabilities and critical incidents has been implemented.
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."

From September 11, 2026 Vulnerabilities and serious incidents that were exploited
Reporting obligation applies
Effective December 11, 2027, the main obligations of CRAs will apply.

01

Responding to reporting obligations is necessary.

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

Secure development is required on a product-by-product basis.

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

Support is needed even after shipment.

Consider the entire product lifecycle.

Our services cover requirements definition, design, implementation and testing, production and shipping, and post-release management.

This is the background image for the section "CRA response has already moved from the preparation stage to the implementation stage."

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.

Points

What you will learn at the seminar

01

Based on the latest trends in laws and regulations
Where should our company start now?
You can understand

This will help you organize your thinking on how to promote CRA (Clinical Research Assurance) compliance within your company.

02

From extensive knowledge
Best practices for implementation
You can understand

You can learn practical approaches to each phase, from system building to development and operation.

03

Towards realizing CRA (Clinical Research Ability) support
Specific options
You can understand

You can learn the key points for selecting the necessary solutions to achieve CRA compliance, tailored to your company's specific challenges.

You can find hints that will help solve your company's challenges.

I am not aware of the latest developments in CRA.

Arrow icon

Keynote Speech 1: [Limited Distribution] Latest Trends in CRAs - Points Manufacturers Should Pay Attention To

(TÜV SÜD Japan Ltd.)

We are unable to decide on a company-wide response system or procedure.
We cannot build a development process that can handle CRA (Clinical Research Assurance) issues.

Arrow icon

Keynote Speech 2: "No Time to Lose" CRA Response – From System Building to Practical Obstacles and the First Steps in AI Utilization

(GMO Cybersecurity by Ierae Co., Ltd. x Macnica)

Unable to translate CRA requirements into product design.

Arrow icon

CRA Countermeasures Themed Sections: Themed sections that you can watch according to your company's specific needs.

(Macnica)

Program

Seminar content

Keynote Speech 1

[Limited Distribution] Latest Trends in CRA - Points Manufacturers Should Pay Attention To

TÜV SÜD Japan Ltd.

A check icon to represent each program item. Latest information on certification and conformity assessment

Keynote Speech 2

CRA response is urgent.
— From system building to practical obstacles and the first steps in AI utilization

GMO Cybersecurity by Ierae Co., Ltd. × Macnica

A check icon to represent each program item. Practical Examples of CRA Response
A check icon to represent each program item. Key points for system building and operation based on user case studies

CRA Countermeasures Themed Sections

We have posted explanatory videos on key points for each countermeasure theme, as well as videos introducing solutions.

A check icon to represent each program item. Secure development processes and threat analysis
A check icon to represent each program item. SBOM/OSS management
A check icon to represent each program item. Vulnerability Management and PSIRT
A check icon to represent each program item. Device ID and Certificate Management
A check icon to represent each program item. Key management and code signing
A check icon to represent each program item. Root of Trust infrastructure design
A check icon to represent each program item. Root of Trust device implementation
A check icon to represent each program item. Device security design
A check icon to represent each program item. OTA, Post-shipment Operation, Long-term Maintenance

Target audience

I recommend this hotel

A check icon to represent each program item. For those considering CRA support, system development, and related tool implementation.
A check icon to represent each program item. Persons in the following departments within the manufacturing industry
  • Security promotion department (information security department, etc.)
  • PSIRT/Product Security Division
  • Product design and development personnel
  • Quality Assurance and Compliance Department
Seminar title
CRA compliance and best practices for advancing it.
Moving on to "What to Do." Macnica A month of answering how to proceed with a total solution
Macnica CRA Conference 2026
exhibition period
November 2, 2026 (Monday) - November 30, 2026 (Monday)
Holding Format
on demand
Entry fee
free
Notes
For Keynote Speech 1, after you register for the seminar, we will verify your eligibility and then grant you access to view it.
Please note that it may take some time to grant you the necessary permissions as we will be performing a verification process.
We apologize for any inconvenience this may cause, and we appreciate your understanding.

Faq

Frequently Asked Questions about On-Demand Seminars

オンデマンド配信のため、お申し込み後は公開期間中いつでもご視聴いただけます。視聴用URLは登録完了後にメールでご案内します。
No. It consists of a keynote speech and sections on specific topics, so you can choose to watch only the topics that interest you. You can also pause your viewing midway and resume watching from where you left off at a later date.
Participation is free of charge. If multiple people will be watching, please register each person individually.

Why not start implementing CRA (Clinical Research Associate) support at your company now?

  • Latest Trends and Overall Approaches for CRAs
  • A breakdown of key issues related to organizational structure, secure development, and vulnerability management.
  • Choose and watch based on topics of interest to your company.
Register for the on-demand seminar (free).
exhibition period
November 2, 2026 (Monday) - November 30, 2026 (Monday)
Holding Format
on demand
Entry fee
free
How to watch
Details will be provided after registration.
Notes
For Keynote Speech 1, after you register for the seminar, we will verify your eligibility and then grant you access to view it.
Please note that it may take some time to grant you the necessary permissions as we will be performing a verification process.
We apologize for any inconvenience this may cause, and we appreciate your understanding.

*We reserve the right to refuse participation to those who apply using a free email address, individuals/students, certification bodies, competing agencies or companies handling competing products, or anyone else the Company deem unsuitable for participation in this seminar.

This is the background image for the section titled "Why not start implementing CRA (Clinical Research Associate) support at your company now?"