Medical Software Application Certification Validation

In medical software application certification and validation, three different systems must be considered. First, the manufacturers and producers of medical devices must validate the software which is used in production, in the products themselves (usually active medical devices), and in the context of the quality management system. The focus in all of this is on the influence of the software on the medical device or service. The manufacturer must ensure to use only verified and suitable software (software validation).

Validation requires documented evidence to prove that a system meets requirements in practical use.

The main question is whether these requirements can be effectively, practically and efficiently implemented. Although validation has been a topic in EN ISO 13485 for a long time, there is still uncertainty regarding the scope and depth of these activities in medical technology.

Our team of experts can answer all the relevant questions on these topics:

• How do I integrate validation activities into the process?
• Do I need a validation master plan?
• Who carries out the validation of medical devices?
• IQ, OQ, PQ*

Whether a medical app is automatically a medical device is not an easy question to answer. The intended use is crucial. A simple monitoring of blood sugar levels does not automatically lead to classification as a medical device. Once the classification of the software has been clarified, questions arise regarding EN ISO 62366 or 62304.

*IQ = Installation Qualification; OQ = Operational Qualification; PQ = Performance Qualification