Software used as a manufacturing quality system, which is part of health products, medical devices, pharmaceutical products, medical device itself or used in the production of health products, should be verified and valided as part of the quality requirement and should be valided/valid. In addition, electronic signature, electronic records, software system should be verified on automated systems using.
TS EN 62304 determines the requirements for “Medical device software – Software life cycle processes” and applies to software on the medical device or software that is the medical device itself.
Within the scope of software validation, studies such as software lifecycle creation, risk analysis, failure situations, design conditions, validation scenarios, traceability analysis are carried out.
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