Frequently Asked Question

Read our IEC 62304 FAQ. Learn what is IEC 62304 and why is this compulsory within US and EU healthcare, medical device software markets.

  • What is IEC 62304 ?

    The international standard IEC 62304 – medical device software – software life cycle processes.

  • What are the top concerns of IEC 62304 ?

    General requirements training, effect of software classification, software development, software management, maintenance, risk management training and several other.

  • IEC 62304 is managed by whom ?

    Who manage IEC 62304? IEC 62304 is a standard which implifies life cycle requirements for the medical software development as well as software within medical devices.

  • Is IEC 62304 compulsory ?

    Yes, it is compulsory in United States and EU. IEC 62304 standard is managed by the European Union (EU) and the United States (US) and offers permission to use as a benchmark to comply with regulatory requirements within both those markets.