M. Cyrille Michaud - consultant pour MD101
Durée de la formation
IEC 62304 is the gold standard of software processes in medical devices. It is a recognized standard by the FDA. The EN version (EN IEC 62304) is a harmonized standard for CE Mark.
Achieving efficient best practice through application IEC 62304 is the path to success of software in your medical devices. Software is incredibly more present now in medical devices than 5 to 10 years ago. With emerging technologies like mobile Health (mHealth), intelligent or communicating devices, software undertakes a large part of functionalities of most recent devices.
Many firms feel that they are not prepared to have their processes about software audited by regulatory agencies.
People working for medical devices or in vitro diagnosis manufacturers:
Quality Assurance and Regulatory Affairs Managers,
Software Project Managers,
Software Development, Risk Management, and Test Engineers.
Objectif de la formation
Learn about main goals of the IEC 62304 standard.
Learn what IEC 62304 requires throughout the lifecycle of software.
Learn how IEC 62304 integrates Risk Management activities.
Learn what documents you should write to prove compliance to the standard.
History of software standards in medical devices.
Terms & definitions
Software Development Process
Software Risk Management