Introduction to the Development of Medical Software
Understand the Regulations. Build Compliant Medical Software.
Medical software development requires more than technical expertise—it demands a thorough understanding of regulatory requirements, international standards, quality management principles, and market access procedures. This introductory course provides a comprehensive overview of the development lifecycle for medical software and Software as a Medical Device (SaMD), from concept and classification through validation, documentation, and commercialization.
Participants will learn how MDR and IVDR requirements apply to software products and gain insight into key standards including ISO 13485, IEC 62304, IEC 82304-1, ISO 14971, and IEC 62366-1. The course also covers conformity assessment, CE marking, UDI, post-market surveillance, and key differences between European and FDA regulatory frameworks, providing a practical foundation for professionals involved in medical software development and compliance.
Upon completion of this course, participants will be able to:
- Explain the regulatory framework for medical software under MDR and IVDR.
- Distinguish between healthcare software, Medical Device Software (MDSW), and Software as a Medical Device (SaMD).
- Define intended purpose and intended use for medical software products.
- Understand software classification principles under MDR and IVDR.
- Identify applicable international standards governing medical software development.
- Describe the role of ISO 13485 in establishing a compliant Quality Management System.
- Understand software lifecycle requirements according to IEC 62304.
- Explain risk management activities based on ISO 14971.
- Recognize usability engineering requirements under IEC 62366-1.
- Understand health software requirements addressed by IEC 82304-1.
- Describe clinical evaluation and software validation expectations.
- Understand technical documentation requirements for software products.
- Explain conformity assessment pathways, CE marking requirements, and UDI obligations.
- Recognize post-market surveillance and incident reporting responsibilities.
- Compare key differences between European and FDA regulatory processes.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This course is intended for professionals working with software-based medical products, including:
- Regulatory Affairs professionals
- Quality Management professionals
- Software Developers and Engineers
- Software Architects
- Project Managers
- Product Managers and Product Owners
- Risk Management professionals
- Clinical Affairs professionals
- Design and Development Engineers
- Medical Device Consultants
- Startups and innovators developing Software as a Medical Device (SaMD)
- Suppliers and service providers supporting medical device manufacturers
- Senior Management involved in medical device development
1. Introduction, Regulatory Requirements and Process Overview
- MDR and IVDR overview
- Medical device software terminology
- MDCG software guidance
- Legal framework for medical software
- Harmonized standards and regulatory expectations
2. Preparing for Development
- Intended purpose and intended use
- Qualification of software as a medical device
- Product classification under MDR and IVDR
- Development planning considerations
3. Implementing Development
- Quality Management Systems (ISO 13485)
- Software lifecycle processes (IEC 62304)
- Health software requirements (IEC 82304-1)
- Software safety classification
- Software of Unknown Provenance (SOUP)
- Risk management (ISO 14971)
- Usability engineering (IEC 62366-1)
4. Evaluation and Documentation
- Clinical evaluation
- Software validation
- Technical documentation requirements
- Verification and validation evidence
- Regulatory documentation expectations
5. Conformity Assessment
- MDR and IVDR conformity assessment pathways
- Technical documentation review
- CE marking
- Declaration of conformity
6. Placing Software on the Market
- Registration requirements
- UDI requirements for software
- Post-market surveillance
- Incident reporting and vigilance
7. FDA Procedures and Additional Considerations
- FDA regulatory overview
- Differences between MDR and FDA approaches
- FDA guidance for software products
- Data protection and cybersecurity considerations
- DiGA and DiPA overview
- Related standards and emerging topics
Developing software for medical devices requires navigating a complex landscape of regulations, standards, quality requirements, and market access obligations. Whether software is embedded in a medical device or qualifies as Software as a Medical Device (SaMD), manufacturers must demonstrate compliance throughout the entire product lifecycle.
This one-day instructor-led training provides a practical introduction to the development of medical software under European and international regulatory frameworks. Participants gain an understanding of the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), applicable guidance documents, and key standards such as ISO 13485, IEC 62304, IEC 82304-1, ISO 14971, and IEC 62366-1. The course follows the complete pathway from defining intended purpose and classification through development, risk management, clinical evaluation, technical documentation, conformity assessment, market placement, and post-market surveillance.
Designed for professionals involved in medical software development, quality, regulatory affairs, and product management, the training helps organizations understand regulatory expectations and establish a foundation for compliant software development practices.
This course is part of a modular medical software training pathway. Participants may continue with advanced modules toward the Specialist Medical Software qualification.
By attending this course, you will:
- Understand the regulatory framework governing medical software in Europe.
- Learn when software qualifies as a medical device or Software as a Medical Device (SaMD).
- Gain insight into MDR and IVDR requirements relevant to software products.
- Understand how intended purpose influences classification and regulatory obligations.
- Become familiar with key medical software standards:
- ISO 13485
- IEC 62304
- IEC 82304-1
- ISO 14971
- IEC 62366-1
- IEC 81001-5-1
- Understand software lifecycle, risk management, usability, validation, and documentation requirements.
- Learn the fundamentals of conformity assessment, CE marking, UDI, and post-market surveillance.
- Gain awareness of key differences between EU and FDA regulatory approaches.
- Benefit from content reflecting current regulatory expectations and guidance.
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Participants who attend at least 90% of the total training duration will receive a Certificate of Attendance from TÜV SÜD Academy.
What is the purpose of this course?
This course provides an introduction to the regulatory, quality, and development requirements applicable to medical software and Software as a Medical Device (SaMD).
Does the course cover MDR and IVDR requirements?
Yes. Participants receive an overview of MDR and IVDR requirements relevant to medical software products.
Will I learn how to determine whether software qualifies as a medical device?
Yes. The course discusses software qualification principles, intended purpose, intended use, and MDCG guidance for classification.
Which standards are covered?
The course introduces:
- ISO 13485
- IEC 62304
- IEC 82304-1
- ISO 14971
- IEC 62366-1
- IEC 81001-5-1
Does the course explain software classification?
Yes. MDR Rule 11 software classification and IVDR software classification principles are covered.
Is risk management included?
Yes. The course introduces medical device risk management using ISO 14971 and discusses software-specific risk considerations.
Does the course cover software lifecycle processes?
Yes. Participants gain an understanding of software lifecycle requirements according to IEC 62304.
Is technical documentation discussed?
Yes. The course reviews software-related documentation requirements under MDR and IVDR.
Does the course cover CE marking?
Yes. The training introduces conformity assessment processes, declarations of conformity, and CE marking requirements.
Are UDI and post-market surveillance included?
Yes. Participants learn about software UDI requirements, registration obligations, post-market surveillance, and incident reporting.
Does the course compare EU and FDA requirements?
Yes. Key differences between European and FDA regulatory approaches are discussed.
Is this course suitable for software developers?
Yes. The course is suitable for developers, software architects, engineers, quality professionals, regulatory specialists, and product managers working with medical software.
Are there any prerequisites?
No prior regulatory expertise is required. The course is designed as an introductory-level training.
What training format is used?
The course is delivered as live instructor-led virtual training and includes presentations, discussions, examples, exercises, and knowledge-sharing activities.
Will participants receive a certificate?
Yes. Participants receive a TÜV SÜD certificate of attendance upon completion.
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