Medical Software Specialist Certification - Classroom (exam included)
3.250,00 EUR
- 5 days
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.
About the program
5 sessions across 5 weeks modules. Contact us for a detailed schedule!
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
Language
Course and material are in English
Level
Intermediate level for specialized professionals
5 Online class meeting
across 5 weeks modules (7,5 hours each) recording available
Interactive online delivery
with the ability to ask questions, engage with peers, and complete exercises.
Study time
60 hours study time recommendation
Coverage of key international standards
including IEC 62304, IEC 82304-1, ISO 14971, and IEC 62366-1
Course documents
provided as PDF for use during and after the sessions.
Exam
Official online exam & course certification included
Learning Outcomes
At the end of this course, you will be able to:
Framework
Understand the regulatory framework for software used in medical devices
Identify
Identify when software qualifies as a Software as a Medical Device (SaMD)
Lifecycle
Apply international standards governing medical software development and lifecycle management
Risk management
Implement risk management strategies for medical software systems
Integrate
Integrate software lifecycle processes into quality management systems
Evaluate
Evaluate usability and human factors in medical software design
Cybersecurity
Address cybersecurity and IT security requirements for medical devices
Regulatory
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
Course timeline
Regulatory Requirements for Medical Software
Lesson 01
- 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
Medical Software Development Standards
Lesson 02
- 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
Risk Management for Medical Software
Lesson 03
- 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.
Usability and Human Factors
Lesson 04
- 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
Cybersecurity for Medical Devices
Lesson 05
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.
Who Should Enroll in this Program?
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
Certification
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
Statements
and equality policy
Licensing and accreditation
This course is offered by AVC according to Partner Program Agreement and complies with the License Agreement requirements.
Equity Policy
AVC does not provide accommodations due to a disability or medical condition of any students. Candidates are encouraged to reach out to AVC for guidance and support throughout the accommodation process.
Frequently Asked Question
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