The standard IEC 62304/A1:2015-06 contains important amendments to the IEC 62304 related to Medical device software. This standard has been approved by CENELEC as EN 62304/A1:2015-10. Some key points:

  • A new and more extensive software safety classification method is provided.
  • Identification and avoidance of common software defects is required.
  • More requrements are now applicable to Class A software, among which software system testing.
  • A new set of requirements has been added to deal with Legacy Software, i.e., software which was legally placed on the market and is still marketed today but for which there is insufficient objective evidence that it was developed in compliance with IEC 62304. Proof of conformity to the standard shall now be demonstrated, and a specific set of requirements has been added for this purpose.
    • A mandatory requirement, among others, requires software system testing.
  • Some system level activities, not covered by IEC 62304, shall be handled according to IEC 82304-1 – “Health software – Part 1: General requirements for product safety”.

MediCon Ingegneria has the knowledge and the resources to develop Medical Devices Software in accordance to IEC 62304/A1, and to plan and implement an adjustment activity for non compliant software.

Contact us for further information