IEC 62304 -standard
IEC 62304 defines the set of processes for life-cycle management of medical device software.
What is IEC 62304?
IEC 62304:2006 defines the set of processes for life-cycle management of medical device software:
- Software development process
- Software maintenance process
- Software risk management process (together with ISO 14971)
- Software configuration management process
- Software problem resolution process
The standard is applicable for all medical devices that include software (driving or influencing) and to softwares that itself are medical devices i.a. Medical device softwares.
IEC 62304 is commonly used together with the quality management system standard ISO 13485 and the risk management standard ISO 14971 for medical devices. Additionally, the standard for Health Software 82304 needs to be considered since 62304 does not cover any validation activities for softwares and IEC 81001-5-1 for security aspects for the software development process.
IEC 62304 Certification – How to certify?
For IEC 62304 you don’t get a certification – you need to develop and certify a Quality management system according to ISO 13485, the standard for quality management system for medical devices, where the IEC 62304 framework is included.
Our services related to IEC 62304
Kasve has extensive experience in planning, development, implementation and management of software development processes that fulfil the IEC 62304 requirements. We support you from the early stages with medical device software classification (including software safety classification A,B,C) throughout the product development phase to market entry.
Kasve also supports customers in creating a requirement fulfilling software development platform and document environment that automatically fulfills the requirements set in the standard. We help you to build up your standard framework to conform to the MDR and related standard requirements for medical device softwares!
Check out our references related to the IEC 62304 standard
Kustannus Oy Duodecim
Read how together with Kasve, Kustannus Oy Duodecim has built a Quality Management System in accordance with the ISO 13485 standard, and is developing software product in accordance with the IEC 62304 standard.
Adamant Health Oy
Read how together with Kasve, Adamant Health built a quality management system on time to enable them to apply for the CE mark for their medical device.
IEC/EN 62304 Workshops and Training
The workshop involves presenting the main features of the product development of medical software and the IEC/EN 62304 standard to the extent that corresponds to the client’s needs.
eQMS
An efficient, easy-to-use and modern quality management system for a medical device manufacturer.
Product Development Health Check
The Product Development Health Check will ensure that your product development project is appropriate and fulfils requirements.
Looking for a quality expert?
We have helped a number of medicinal device manufacturers, testing and clinical laboratories, and start-ups develop their operations.
