Medical Device Software Lifecycle Management – Implementation Training based on IEC 62304

In this course, the standards IEC 62304, Amendment 1 and IEC 82304-1 will be presented in a practical way. Implementing these software standards is a challenge for many manufacturers of medical devices, as a whole range of processes, some of which are new, are required. You will get a basic overview of the essential contents of the standard with the required processes describing the software life cycle. By means of practice-relevant exercises, the handling of the standard will be deepened, and the implementation with regard to process design and documentation will be practiced. The aim of the course is to learn the requirements for the development and approval of medical software and to be able to implement them for their application.

• Introduction to Medical Device Software’s
• Requirements for conformity assessment procedure for medical device software
• Definitions of terms
• Requirements of the software standards IEC 62304, Amendment 1:2015 and IEC 82304-1
• Software safety classification
• Software development process
• Software maintenance process
• Software risk management process
• Software configuration process
• Software problem resolution process
• Methods of verification
• Integration with other standards and validation
• Implementation of the standard with existing medical software
• How to decide on the State of the Art (STOA)
• Practical elaboration of important aspects of the standard through group work or workshops

• Quality/Regulatory Team
• Senior Management
• Middle Management
• Software Developers
• Production Team
• Engineering Team
• Medical Device Consultants

• Participants attending the course are preferred to have prior knowledge of medical devices and quality management system.

• Acquire in-depth knowledge of the software standards IEC 62304, Amendment 1:2015 and IEC 82304-1.
• Understand how to implement the software standards IEC 62304, Amendment 1:2015 and IEC 82304-1 in your company.
• Gain knowledge on know-how for optimizing the development processes of medical software.
• Best practice-relevant exercises for deepening the handling of the standard.

An online open book examination will be conducted at the end of the course.

• Examination Test Duration- 1 hour 30 minutes

• Minimum Passing Criteria - 70% overall

TÜV SÜD South Asia will issue a completion certificate to participants who successfully pass the examination; non-successful participants will be issued an attendance certificate

1. When can I get the certificate?
Certification for the Medical Device Software Lifecycle Management – Implementation Training based on IEC 62304 will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?
One day before the commencement of the training program.

3. How do I pay the fees for training?
Online mode.

4. What are the benefits of the Medical Device Software Lifecycle Management – Implementation Training based on IEC 62304?
Understanding the importance of risk management, helping organizations identify potential hazards early in the development process
Learn about the framework for efficient software development, leading to increased efficiency and productivity
Understand the implementation needs and demonstrate compliance with IEC 62304 and other relevant standards

5. Is there any refund policy for the paid fees?
Please refer to Cancellation and Refund policy page.