Overview

Navigate Course Details

Course Overview

  • Duration: 8 hours
  • Cost: 950 USD

This course provides an in-depth exploration of essential medical device software regulations, equipping participants with a thorough understanding of the regulatory framework essential for software development and compliance. Participants will examine important aspects of ISO/IEC 62304, examining software lifecycle processes, and review the application of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746 for devices in the European market.

Learning Objectives
By the end of this course, participants will:

  • Understand quality system and risk management requirements for medical device software
  • Learn software lifecycle processes as defined by ISO/IEC 62304
  • Apply software safety classification principles
  • Develop software development planning strategies
  • Conduct software requirements analysis and architectural design
  • Implement and verify software units effectively
  • Manage software configuration and problem resolution processes
  • Determine software compliance and applicability with relevant regulations
  • Identify the relationship and relevance between ISO/IEC 62304 and other applicable standards

Ideal Target Audience
This course is designed for professionals involved in development, regulation, and compliance of medical device software, including software engineers, regulatory affairs specialists, and product managers. It is particularly valuable for those looking to deepen their knowledge of ISO 62304, MDR, and IVDR requirements to facilitate a more seamless compliance journey.

Instructor Information
Subramanian Murugan, PhD

Dr. Subramanian Murugan has over a decade of experience in regulatory affairs and quality assurance, specializing in medical device software regulations. He has successfully guided numerous regulatory submissions, helping manufactures demonstrate compliance with applicable global regulations. His expertise includes:

  • Risk Management Frameworks (ISO 14971:2019)
  • Software Lifecycle Processes (ISO/IEC 62304)
  • Usability Engineering (ISO/IEC 62366)
  • Cybersecurity Standards (ISO 27001)

Benefits of our Training

  • Gain Confidence: You can gain a thorough understanding of software development lifecycle for medical devices, including software development, validation, maintenance and risk management aimed at facilitating patients’ safety and effectiveness. Training on the relevant standards will allow you to address necessary regulatory requirements and help you navigate the intricacies of EU regulatory systems.
  • Expert Instructors: Our experienced trainers bring real-world knowledge and industry-leading insights to the classroom. They have a deep understanding of testing and certification at CSA Group and work with world-class manufacturers.
  • Private or Public: We offer both public and private courses. For organizations with 10 or more participants, we can administer private training courses — allowing your team to ask questions and receive guidance tailored to your business. For organizations with less than 10 participants, we recommend our public courses. Our public courses have been designed by our industry experts to help your team understand a range of complex topics.
  • Hands-On Learning: Engage in practical exercises, case studies, and simulations to reinforce your understanding.
  • Certificate: Earn a Certificate of Completion upon successful completion of each course.

Go to the Top