Medical Device Software Lifecycle per IEC 62304

Scheudle (all times EST)

Day 1: 9:00am - 5:00pm

Day 2: 9:00am - 5:00pm

About the Training

GMED North America has created a 2-day training session, to equip medical device manufacturers with the right strategy to ensure their Medical Device software processes/documentation can withstand heightened scrutiny from NBs.

This comprehensive 2-day course covers the processes defined in IEC 62304 including software development, maintenance, risk management, configuration management, and problem resolution. It includes various aspects planning and documentation of software development, software requirements, software architecture, software safety classification, software testing, and addressing SOUP/OTS software.

The course provides an overview on European and U.S. regulatory requirements for software development and validation, standard documents or guides useful for declaring compliance with regulatory requirements, Implementation of quality management principles for medical device software development.

For program and more information, click here.