COURSE OVERVIEW

Software as a Medical Device (SaMD)

Our industry-leading experts have created a course to help you understand the requirements of IEC 62304 and the importance for medical device manufacturers.
This course explores the IEC 62304 standard clause by clause to ensure a thorough understanding of the requirements.

During this course, you will be provided with an understanding of how IEC 62304 aligns with Design Control and Risk Management towards meeting the new European MDR and IVDR and the US requirements of FDA 21 CFR 820, QMSR.
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Course Information

Course Syllabus 

Course Agenda

This training course will explore the following topics:

Regulatory Overview
- ISO 13485 Software Requirements
- MDR 2017/745 / IVDR 2017/746 Software
Requirements
- MDR (UK) 2002 Software Requirements
- FDA 21 CFR Part 820

- MDCG Guidance / Consensus Guidance

- Software Definitions
- Software Development Life Cycle (SDLC)
- Software Classification
- Security & Data Protection


Practical
- Software Development Planning
- Intended Use & User Needs

Learning Objectives

  • Understand the purpose and structure of IEC 62304
  • Understand the key terms and definitions used through IEC 62304 (incl. SaMD, Software as a component or accessory, embedded software)
  • Describe and understand all elements of IEC 62304 and the deliverables required based on Software Risk Classification
  • Understand the interconnection between Software Development, Design Control and Risk Management and Human Factors/Usability Engineering
  • Explain with working examples the key deliverables required from IEC 62304
  • Understand when IEC 60601 is required
  • Identify Label Requirements for Software including UDI

Who Should Attend? 

  • Software Engineers
  • Software Managers
  • Quality Managers
  • Design Assurance
  • Managers Software
  • Quality Engineers
  • Quality Engineers
  • Regulatory Affairs Professionals 
  • Internal Auditors

Don't just take our word for it

Witness it first hand, directly from our previous attendees 
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''Thanks to this training, I now feel more confident and equipped to navigate the challenges of developing and maintaining SaMD products. I have already started implementing the knowledge gained from the training into my current projects, and I can see the positive impact it has had on our processes.''

Chloe B

MediGlobal 
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''The trainers demonstrated deep expertise in the subject matter and effectively communicated complex concepts in a clear and concise manner. The training materials provided were also top-notch, offering practical examples that enhanced my understanding of SaMD development and regulatory requirements.''

Sean H

Cambridge University 

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