Validation of Software as a Medical Device and EN IEC 62304

The course content is organised into clear sections that build from regulatory foundations through to practical lifecycle activities. 

Medical Device Software Regulations 

The course covers the US requirements for the development of Software as a Medical Device and Software in a Medical Device and European requirements as outlined in EU MDR 2017/745 and EU IVDR 2017/746. The course goes on to demonstrate how to achieve compliance with these regulations through the implementation of EN IEC 62304 and related standards. 

Contents of EN IEC 62304 

The course examines in detail the requirements for development, validation and maintenance of Medical Device software in accordance with EN IEC 62304. The course covers the Software Development Process, The Software Maintenance Process, Software Risk Management, Configuration Management and the Software Problem Resolution Process. 

Risk Assessment 

This section covers the objectives for risk assessment, and discusses the various standards such as ISO 14971 and IEC/TR 80002-1 and techniques involved and how these relate to EN IEC 62304. The programme covers the implementation of risk assessment to ensure critical risks are identified and the correct level of validation is carried out. 

The training involves practical exercises covering all the above topics, with learners encouraged to work on examples from their own workplace as part of these practical exercises.  If required, content may be tailored to reflect your organisation’s specific processes, risk profile and regulatory setting. 

The Software Development Life Cycle 

The software development life cycle, including planning, design, development, testing and maintenance, of a medical device software project are described with details on the contents of key documents and activities such as: 

• Software Development Plans 
• Software Classification 
• Requirements Specification 
• Software Specifications and Software Detailed Design 
• Coding Standards and Code Reviews 
• Dealing with Software of Unknown Provenance (SOUP) 
• Software Unit Testing 
• Integration and System Testing 
• Software Maintenance Plans 
• Software Problem Resolution 
• The Relationship to Design Controls 

The relationship between EN IEC 62304 and the Design Control Requirements of 21 CFR part 820 and ISO 13485 are explored and methods of compliance outlined. 

This training is designed for professionals working in the medical device sector who are involved in Medical Device software development, quality assurance, compliance or validation. It is particularly beneficial for those who need a practical understanding of EN IEC 62304 and related regulations. 

The training is particularly beneficial for: 

• Software engineers, developers and project leads 
• Quality and regulatory professionals 
• Validation and risk management specialists 
• Managers overseeing medical device software projects 

Learners gain the practical knowledge and confidence necessary to ensure projects meet both European and US regulatory requirements. 

A good standard of written and spoken English is important to engage effectively with this programme. 

On successful completion of the training, learners will be able to: 

• Apply the principles of Medical Device Software Development and Validation in compliance with EN IEC 62304 
• Develop and maintain documentation across the full software development lifecycle 
• Implement requirements for software design, testing and maintenance, including Software of Unknown Provenance (SOUP) 
• Integrate software validation practices with risk management techniques in line with ISO 14971 and IEC/TR 80002-1 
• Apply effective configuration management and problem resolution processes 
• Relate EN IEC 62304 requirements to US 21 CFR 820 and ISO 13485 Design Controls 

These outcomes ensure that learners return with the practical skills and knowledge necessary to deliver compliant medical device software development and validation projects within their organisations. 

Our tutors are industry specialists with extensive experience in medical device software development and validation. Each tutor brings a wealth of industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support. 

Learners benefit from practical insights and ongoing support from recognised experts. 

• 

  John Lafferty

  John Lafferty is a Quality professional with over 25 years expe...

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To consolidate learning and reinforce key concepts, learners complete a post-course assessment. The assessment; 

• Checks understanding of the course content and practical scenarios 
• Assesses practical understanding and application 
• Is completed within one week of course completion 

Successful learners receive a Certificate of Achievement, in addition to their Certificate of Attendance 

Our training approach is practical, highly interactive and discussion-based, with flexibility to meet organisational needs: 

Support includes: 

• Emphasis on hands-on application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation. 
• Pre-training consultation for In-Company courses to tailor content to organisational needs 
• Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance. 
• Real time support from expert tutors 

Class sizes are generally limited to 12-15 to support personalised learning and individual support. 

Learners who complete this course often continue to deepen their skills in: 

• Software Validation (for Production and QMS applications) 
• Medical Device Risk Management & ISO 14971 
• Process Validation & Equipment Validation 
• Process Validation for Medical Device Manufacturing  
• Technical Writing Skills 

These programmes build deeper expertise and provide complementary skills for advancing careers in medical device compliance and validation.