Embedded or standalone software that is marketed as a medical product must fulfill special requirements. In addition to safety and effectiveness, they also include the definition and application of software life-cycle processes.
To fulfill the regulatory safety and performance requirements for medical software, the implementation of the IEC 62304 process standard is internationally accepted as the current state of the art. Based on the risk management process according to ISO 14971, the standard defines requirements for the life-cycle processes and the technical documentation that must be taken into account when manufacturing and servicing medical software.
Due to the high market requirements and the associated cost pressure, cross-product establishment and applying life cycle processes in a manner that is tailored to continuous optimization during the creation of medical software has become a critical factor for success.
To certify the conformity of your life-cycle processes with IEC 62304 requirements, our neutral experts conduct a multi-level process audit. Once all the requirements have been met, it is certified with the certification and issuance of the VDE quality seal, "Certified Life-Cycle Processes". Manufacturers and service providers that develop medical product software can use the VDE quality seal for advertising purposes and place it on brochures or publish it online, for instance.
The certification process is closely aligned with the DIN EN ISO/IEC 17065 standard and comprises a 3-year audit cycle, consisting of an initial certification audit and two monitoring audits. One evaluation of the established lifecycle processes, the continuous improvement process and a random inspection of the technical documentation takes place per audit unit.
Benefits for you
- Ensure a standards-compliant software development process across several product groups, service areas, or development departments
- Legal and planning certainty when entering markets
- Continuous feedback regarding potential for improvement
- Information on current developments in the relevant standardization bodies
- Economic benefits during process certification if the medical software is often updated in short time intervals, developed at a large scale, or used in various medical equipment
- Cost reduction of up to 30% for medical equipment software tests that must be performed by the VDE Institute as part of electrical safety according to IEC 60601-1
- Use of the VDE mark as a quality seal for OEM manufacturers and development service providers