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Navigating the jungle of regulations, certification requirements, and management systems can be challenging. We help ensure market access and compliance by offering comprehensive services — from preliminary assessments to certification and expert resources.
Whether your company is just starting out or already close to certification, our experts will support the process so you can focus on what matters most — growing your business. Choose the service that matches your current situation and take your company to the next level.
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Do you already know the standards?
ISO 9001
Quality management system (General)
What is it?
An international standard for quality management systems.
Who is it for?
All companies for whom a quality management system is important or required by customers.
Why is it needed?
It brings credibility, helps attract larger clients, and is often a requirement when working with major clients.
ISO/IEC 27001
Information Security Management System
What is it?
A standard for managing information security and risk management.
Who is it for?
Companies that handle personal data or significant volumes of information.
Why is it needed?
It is a customer requirement especially in critical industries, and it helps with responding to security queries.
KaTaKri
National Security Audit Criteria (KATAKRI)
What is it?
Finland’s national security standard.
Who is it for?
Suppliers to government agencies and operators in security-critical sectors.
Why is it needed?
Often a requirement in requests for tenders and a prerequisite for handling classified information.
PiTuKri
Security Audit Criteria for Cloud Services (PiTuKri)
What is it?
A standard for the security of cloud services.
Who is it for?
Suppliers to government agencies and companies providing cloud services.
Why is it needed?
A requirement in requests for tenders involving the handling of classified information in cloud environments.
SOC 2
ISO/IEC 27001
Information Security Management System
What is it?
A standard for managing information security and risk management.
Who is it for?
Organizations that handle personal data or significant volumes of information.
Why is it needed?
A common customer requirement, especially in critical industries, and a valuable asset in responding to security questionnaires.
ISO 14001
Environmental Management System
What is it?
A standard for managing and reporting environmental impacts.
Who is it for?
Companies whose operations have an environmental impact or who want to emphasize their commitment to sustainability.
Why is it needed?
A customer requirement, an environmental permit condition, or a marketing advantage.
ISO 45001
ISO 13485
Quality Management System for Medical Devices and Software
What is it?
A quality management standard specifically designed for medical devices and related software.
Who is it for?
Suppliers of medical devices and their components.
Why is it needed?
It is a prerequisite for obtaining CE marking in Europe and FDA approval in the United States.
ISO 14971
Risk Management for Medical Devices
What is it?
A standard for risk management related to medical devices.
Who is it for?
Suppliers of medical devices and their components.
Why is it needed?
It is a mandatory part of the ISO 13485 quality system and helps model the safety risks associated with the use of the device.
AAMI TIR 57
Product Cybersecurity for Medical Devices
What is it?
A standard for managing cybersecurity risks in medical devices and related software.
Who is it for?
Suppliers of medical devices and their components.
Why is it needed?
Helps identify and model cybersecurity risks and supports compliance with industry requirements.
Act on the Processing of Social and Healthcare Client Documents
Act on the Processing of Social and Healthcare Client Documents
What is it?
A Finnish law regulating the security and handling of data in social and healthcare information systems
Who is it for?
Suppliers of social and healthcare information systems.
Why is it needed?
It is a prerequisite for connecting to Kanta Services and for entering the Finnish market with social and healthcare software
THL regulations
Cybersecurity and Certification for Social and Healthcare Information Systems
What is it?
Requirements issued by the Finnish Institute for Health and Welfare (THL) for social and healthcare information systems.
Who is it for?
Suppliers of social and healthcare IT systems.
Why is it needed?
Mandatory for connecting to Kanta Services and for entering the Finnish market with healthcare software
IATF 16949
Quality Management System for Automotive Components
What is it?
A quality management system standard for the automotive industry.
Who is it for?
Suppliers of automotive components.
Why is it needed?
It is a requirement set by automotive manufacturers and a prerequisite for operating in the industry.
ISO/SAE 21434
Cybersecurity in the Automotive Industry
What is it?
An international standard for managing cybersecurity risks in road vehicles
Who is it for?
Suppliers and manufacturers of automotive components and systems
Why is it needed?
Helps meet legal requirements in Europe (e.g. UNECE WP.29) and is increasingly required by car manufacturers
ISO/TS 50701
Cybersecurity in Railway Systems
What is it?
A standard for managing cybersecurity in railway applications.
Who is it for?
Suppliers of railway components and systems.
Why is it needed?
Supports compliance with European regulatory requirements and helps manage cybersecurity risks in rail transport environments
ISO/TS 50701
Cybersecurity in Railway Systems
What is it?
A standard for managing cybersecurity in railway applications.
Who is it for?
Suppliers of railway components and systems.
Why is it needed?
Supports compliance with European regulatory requirements and helps manage cybersecurity risks in rail transport environments
ISO/TS 50701
Cybersecurity in Railway Systems
What is it?
A standard for managing cybersecurity in railway applications.
Who is it for?
Suppliers of railway components and systems.
Why is it needed?
Supports compliance with European regulatory requirements and helps manage cybersecurity risks in rail transport environments