Software CE Marking

It is the requirement that the software used in medical devices must be validated for its complete life cycle phases.

ISO 13485 requires that organizations establish documented procedures for the validation of the computer software used in production. The intended application of computer software in monitoring and measuring devices must be confirmed before initial use.

The new Medical Device software validation method (life cycle process model) developed is known as EN 62304. The new standard covers software development & maintenance, risk management according to ISO 14971, partitioning and safety classification of software items, and software process management.

As per clause 3.12 of EN 62304:2006 a Medical Device Software means “SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE in its own right” The MANUFACTURER shall assign to each SOFTWARE SYSTEM a software safety class (A, B, or C) according to the possible effects on the patient, operator, or other people resulting from a HAZARD to which the SOFTWARE SYSTEM can contribute.

The software safety classes shall initially be assigned based on severity as follows:

  1. No injury or damage to health is possible
  2. Non-SERIOUS INJURY is possible
  3. Death or SERIOUS INJURY is possible

The software needs to classify as per Medical Device Directive. The class of medical software can be easily found out if it is used in connection with other Medical Equipment. If it is used as standalone equipment based on the Risk analysis and Indented application the class can be found out.

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