Medical Software Specialist Certification - Online Class (exam included)

Medical Software Specialist Certification - Online Class (exam included)

5 sessions across 5 weeks modules

Contact us for detailed schedule!

The Medical Software Specialist Certification is a practical, industry-focused programme designed to equip professionals with the regulatory, technical, and risk management knowledge required to develop and manage software used in medical devices and digital health applications.

As healthcare becomes increasingly driven by digital technologies, software used for diagnosis, treatment, and patient monitoring must comply with strict regulatory standards and safety requirements. This course provides a comprehensive introduction to the legal, regulatory, and technical frameworks governing medical software development, with a strong focus on the European regulatory environment.

Through expert-led sessions, real-world examples, and interactive discussions, participants will learn how to navigate complex medical device regulations, integrate software lifecycle management into quality systems, and ensure compliance with international standards such as IEC 62304 and ISO 14971.

By the end of the programme, learners will have the practical skills and regulatory insight required to support the development, approval, and lifecycle management of software used in medical technology.

Key Features

• Course and material in English
• Intermediate level for specialized professionals
• 5 Days Online class meeting (7,5 hours each) across 5 weeks modules (Contact us for detailed schedule)
• 60 hours of recommended study time
• Coverage of key international standards including IEC 62304, IEC 82304-1, ISO 14971, and IEC 62366-1
• Interactive online delivery with the ability to ask questions, engage with peers, and complete real-case exercises.
• Course documents provided as PDF for use during and after the sessions.
• Official online exam & course certification included
• Course recording available

Learning Outcomes

Upon successful completion of the course, participants will be able to:

• Understand the regulatory framework for software used in medical devices
• Identify when software qualifies as a Software as a Medical Device (SaMD)
• Apply international standards governing medical software development and lifecycle management
• Implement risk management strategies for medical software systems
• Integrate software lifecycle processes into quality management systems
• Evaluate usability and human factors in medical software design
• Address cybersecurity and IT security requirements for medical devices
• Support regulatory approval and compliance throughout the product lifecycle
• Incorporate legal and normative requirements early in the development process, helping reduce risks and ensure safe, compliant products

Target Audience

This course is designed for professionals involved in the development, regulation, and management of medical software and digital health products, including:

• Regulatory Affairs professionals
• Quality Management specialists
• Software and Systems Engineers
• Usability and Human Factors Engineers
• Requirements Engineers
• Project Managers and Product Managers
• Risk Management professionals
• IT and technology specialists in medical device companies
• Consultants working with medical software products
• Start-ups and newcomers entering the medical technology sector

Course Content

Module 1 – Regulatory Requirements for Medical Software

• Key terminology and definitions related to medical software
• Overview of relevant regulations and standards, and how they relate to other essential medical device standards
• Core requirements of IEC 62304 (Medical Device Software – Software Lifecycle Processes)
• Software security classification and its importance in development
• The medical software development lifecycle
• Processes for software maintenance and updates
• Risk management processes specific to medical software
• Software configuration management
• Procedures for software problem identification and resolution
• Introduction to IEC 82304-1 (Health Software – General requirements for product safety)
• Validation approaches for medical device software
• Applying standards to existing or legacy medical software systems
• Interactive group work and practical exercises

Module 2 – Medical Software Development Standards

• Key terms and concepts used in medical software and digital health
• Overview of applicable regulations and standards, and how they relate to other core medical device requirements
• Key principles and requirements of IEC 62304 (Medical Device Software – Software Lifecycle Processes)
• Understanding software safety and security classification
• Medical software development lifecycle and best practices
• Managing software maintenance and updates
• Risk management processes for medical software systems
• Software configuration and version control practices
• Handling software issues through structured problem resolution processes
• Introduction to IEC 82304-1 (Health Software – General Requirements for Product Safety)
• Methods for validating medical device software
• Applying standards to existing or legacy medical software
• Collaborative group activities and practical exercises

Module 3 – Risk Management for Medical Software

• Introduction to risk management principles and key terminology
• Overview of the risk management process in accordance with ISO 14971
• Risk management analysis methods and documentation requirements
• Risk analysis techniques for software, including scenario-based risk analysis, software architecture evaluation, root-cause analysis, FTA and FMEA, management of third-party components, and concepts from IEC/TR 80002-1
• Conducting risk assessments and preparing the risk management report
• Risk considerations during production and post-production activities, including configuration management, deployment, and updates to databases, operating systems, and other components
• Managing changes and evaluating their impact on risk
• Overview of key regulatory and normative requirements, including EN ISO 14971:2019/A11:2021, and references to ISO/TR 24971 and IEC/TR 80002-1:2009.

Module 4 – Usability and Human Factors

• Regulatory requirements under MDR and IVDR
• Overview of relevant standards, particularly IEC 62366-1:2015 + AMD1:2020
• Incorporating usability engineering into the risk management process
• Integrating usability engineering practices into the product development lifecycle
• Conducting user research as the foundation for the Use Specification in accordance with IEC 62366-1
• Developing use scenarios, identifying critical tasks, and analysing potential use errors
• Creating user interface specifications and defining practical UI requirements
• Using formative evaluations to refine and improve prototypes
• Performing summative evaluations to validate risk control measures
• Preparing the Usability Engineering File and Human Factors Engineering Report

Module 5 – Cybersecurity for Medical Devices

Explanation of key terminology across the areas of:

• Information security
• IT security
• Operational security

Overview of cybersecurity requirements for medical devices based on:

• Relevant standards
• Applicable laws and regulations
• Official guidance documents

Practical tips, methods, tools, and helpful resources to support the effective implementation of cybersecurity requirements.

Exam & Certification Detail

• Final Assessment: The course concludes with an online exam (typically multiple-choice) testing core knowledge from all five modules.
• Final Discussion: An individual discussion on course content complements the exam.
• Certification: Participants who successfully complete the assessment receive a Medical Software Specialist Certificate
• Format: All course elements (exam and certificate) are conducted and issued online
• The certificate demonstrates competence in regulatory compliance, risk management, and lifecycle management of medical software products