QA Standards for MedTech

by itsbusiness AG

Across industries, standards are an important way to safeguard product conformity while simultaneously harmonizing requirements both nationally and internationally. Quality assurance is vital to ensure that the producer correctly applies standards.

The main standards for medical devices cover the quality management system, risk management, software life cycle processes, and usability engineering.

These standards have the following impact on Software Quality: there has to be a Quality Management system in place which meets the requirements for the regulations; and the Software Lifecycle Process must be followed according to risk classification, see table - Effect of safety classification on required development process documentation

Regulatory Requirement Harmonized Standard
Quality Management System

ISO 13485

Risk Management

ISO 14971

Software Lifecycle Processes

IEC 62304

Usability Engineering

IEC 62366

Quality Management System

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an ISO standard representing the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

Risk Management

ISO 14971 is the application of risk management to medical devices is an ISO standard for the application of risk management to medical devices.

Software Lifecycle Processes

The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices.

Usability Engineering

The international standard IEC 62366 medical devices - Application of usability engineering to medical devices is a standard which specifies usability requirements for the development of medical devices.

Any medical device entering the European market must be assessed by a “conformity assessment procedure.” This is a prerequisite for declaring the conformity and for attaching the CE-mark.

With our experienced consultants, itsbusiness supports you in the development of the basics for software quality assurance, carries out an assessment together with you for a TARGET/ACTUAL analysis, and submits an action plan as well as for the implementation. Within the scope of the implementation, we support you in the implementation of the action plan and ensure the achievement of the objectives.


If you have questions or need more information, please contact:

Andrew Connell
Test Automation Expert, itsbusiness AG​

+41 31 370 32 05​

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