Training Features

Medical Device Software (SW) Development Process as per IEC 62304

Join us on 27 and 31 July 2026 to strengthen your understanding of IEC 62304 and build confidence in meeting global software regulatory expectations.
Format

Virtual Training

Level

Advanced

Date

27 and 31 July 2026

Time

09:00 - 17:00 CET

Duration

2 x 8 hours

Trainer

Coenraad Davidsdochter

Certificate

Certificate included

Price

€ 1495 or equivalent currency

IEC 62304 Essentials for Medical Device Software

Medical device software development requires a structured approach to ensure safety, effectiveness, and regulatory compliance. Whether that is embedded software or software a as a medical device (SaMD). IEC 62304 provides a framework for the software development lifecycle, covering risk management, documentation, verification, and maintenance. Compliance with IEC 62304 is essential for meeting regulatory requirements under the EU MDR 2017/745, IVDR 2017/746, and FDA software guidance. 

Led by Coenraad Davidsdochter, this interactive training provides a practical understanding of IEC 62304, guiding participants through the key requirements for software lifecycle processes, classification, risk management, and validation. Participants will learn how to implement a compliant software development process and prepare documentation for regulatory submissions.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
A structured and compliant software development process is key to ensuring safe and effective medical device software. This training introduces the IEC 62304 framework and explains how to apply its lifecycle, risk management, and documentation requirements to both embedded software and software as a medical device. 

Participants gain practical guidance on implementing compliant processes and preparing documentation for regulatory submissions.
Key Learning Objectives
  • Understand the software development lifecycle requirements under IEC 62304
  • Learn how to classify medical device software based on risk
  • Implement software risk management in alignment with ISO 14971
  • Gain insights into software verification, validation, and testing processes
  • Learn how to document software development activities for regulatory submissions
  • Understand software change management, maintenance, and post-market obligations
  • Ensure compliance with MDR, IVDR, and FDA software requirements.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in two sessions, lasting 8 hours each, providing a focused and efficient learning experience. The sessions will take place on 27 and 31 July 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 23 and 27 February, 5 and 7 May, and 22 and 29 October 2026. More information can be found on the registration pages.
Who Should Attend?
  • Software developers and engineers working on medical device software
  • Regulatory Affairs professionals ensuring software compliance
  • Quality Assurance managers integrating software lifecycle processes into QMS
  • Risk management professionals handling software-related risks
  • R&D teams involved in software design and development
  • Verification and validation engineers responsible for software testing
  • Professionals preparing MDR, IVDR, or FDA submissions for software-based medical devices.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory framework for medical device software, including IEC 62304, MDR and IVDR expectations, FDA requirements, and links to ISO 13485, ISO 14971, and IEC 82304/1.
  • Software classification under IEC 62304, covering safety classes A, B, and C, the risk-based approach, and alignment with regulatory expectations.
  • Software development lifecycle according to IEC 62304, including planning, requirements, architecture, design, implementation, and coding practices.
  • Software risk management, integrating ISO 14971, identifying software hazards, applying controls, and documenting verification of risk measures.
  • Verification, validation, and testing of medical device software, including unit, integration, and system testing, and traceability between requirements, risks, and tests.
  • Software maintenance and change control, including updates, patches, post-market surveillance, cybersecurity considerations, and MDR and IVDR monitoring requirements.
  • Software documentation and regulatory compliance, including preparation of the software development file, documenting lifecycle activities, and addressing expectations of Notified Bodies and the FDA.
  • Requirements for software of unknown provenance (SOUP).

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

Coenraad Davidsdochter

Coenraad Davidsdochter, a Senior Consultant in Software and Artificial Intelligence, brings over 20 years of software development experience and more than a decade in establishing and managing Quality Management Systems (QMS) compliant with ISO 13485, MDD 93/42/EEC, MDR 2017/745, and GDPR 2016/679, and has extensive expertise in areas such as technical file documentation, risk management, clinical evaluations, and information security.