Frequently Asked Question
- What is IEC 62304 ?
- 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.