Understand the software development and validation requirements
2-day training session (split over 3 consecutive half-days of training) | Virtual Classroom
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 of 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, and implementation of quality management principles for medical device software development.
Ali Homaida Senior Compliance Engineer – Active Medical Devices at 601 Consultancy Ltd
Ali Homaida is an accomplished IEC 60601-1 Compliance Engineer, Consultant, Product Reviewer, and Trainer in the medical device industry.
With a background in biomedical engineering, he has worked with test houses in compliance assessment of electrical medical devices including safety testing, risk management files evaluation, usability engineering, and medical devices software.
We offer a variety of training courses and we focus on your challenges and provide our attendees with a clear “take-home” value.
