ISO 62304

Software is often an integral part of Medical Device technology.  Establishing  the  safety   and effectiveness  of  a  Medical Device  containing  software  requires  knowledge  of  what  the  software  is intended to do and demonstration that the use of the software fulfils those intentions  without causing any unacceptable risks.

ISO 62304 standard provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of Medical Device Software. ISO 62304 standard provides requirements for each life cycle process. Each life cycle process is further divided into a set of activities, with most activities further divided into a set of tasks.

Notified bodies and Certification agencies will not conduct and Issue certificate against ISO 62304 standards.

To know more about the standard requirement – Click here

Benefits of Implementing ISO 62304:

  • Compliance to MDD 2007/47/EC
  • Compliance with current FDA regulations and in the preparation of 510(k) submissions.
  • Software risk analysis support the device safety and performance claims?
  • Your quality system includes appropriate software-related procedures.
  • Verification of risk reduction and control methods exercised.

We have the technical experience to help organizations implement ISO 62304, which is accepted by US FDA also.

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