Compliance with IEC 62304/82304 for Medical Device Software

IEC 62304 is harmonized under Regulation (EU) 2017/745 and is therefore a key standard for demonstrating conformity with MDR requirements related to medical device software lifecycle processes. It addresses software development, maintenance, configuration management, problem resolution, software safety classification and software risk management activities.

IEC 82304-1 complements IEC 62304 by addressing product-level requirements for health software, including validation, safety, security, accompanying documentation, and post-market aspects. Since IEC 82304-1 is referenced within IEC 62304, it is highly relevant for establishing a complete MDR-aligned software documentation framework.

This training provides a practical understanding of both standards and their relevance for MDR technical documentation, conformity assessment, audits, and Notified Body reviews. It also addresses the application of IEC 62304 to AI systems embedded in medical devices and medical device software, including the additional lifecycle considerations introduced by data-driven development, model validation, performance monitoring, change control and regulatory expectations under the MDR and where the EU AI Act applicable.

Participants will learn how to structure software lifecycle processes, determine software safety classification, integrate software risk management with ISO 14971 and prepare documentation that supports regulatory submissions and conformity assessment.

Key Topics Covered:

• Regulatory relevance of IEC 62304 as a harmonized standard under the MDR

• Overview of IEC 62304 and IEC 82304-1: scope, structure, purpose and key differences

• Applicability to embedded software, standalone medical device software, health software products, and AI-enabled medical device software

• Application of IEC 62304 lifecycle processes to AI systems embedded in medical devices

• Software safety classification according to IEC 62304: Class A, B and C

• Impact of software safety classification on lifecycle activities and documentation depth

• Software development lifecycle processes: planning, requirements, architecture, detailed design, implementation, verification, integration, system testing and release

• AI-specific lifecycle considerations: data management, training, validation, testing, performance monitoring, model updates, and change control

• Software maintenance, configuration management, problem resolution and post-market software changes

• Integration of software risk management with ISO 14971

• Product-level expectations under IEC 82304-1, including validation, safety, security, accompanying documentation and post-market considerations

• Documentation expectations for MDR technical documentation and Notified Body reviews

• Interface with EU AI Act expectations, where applicable, for AI-enabled medical device software

• Common gaps and nonconformities identified during audits and technical file assessments

• Case studies, practical examples and Q&A sessions

Benefits:

• Understand why IEC 62304 is especially important as a harmonized standard under the MDR

• Gain a clear understanding of IEC 62304 and IEC 82304-1 and their relevance for medical device software and health software

• Learn how to correctly determine software safety classification and apply proportionate lifecycle requirements

• Understand how IEC 62304 can be applied to AI-enabled medical device software and AI systems embedded in medical devices

• Recognize AI-specific lifecycle challenges related to data, model development, validation, monitoring and change control

• Understand how to structure software lifecycle documentation to support MDR technical documentation and regulatory submissions

• Recognize how software risk management links to ISO 14971 and overall device risk management

• Identify common audit findings and technical documentation gaps related to software development and maintenance processes

• Strengthen software development, maintenance and documentation practices in line with regulatory and Notified Body expectations

• Understand the interface between software lifecycle compliance, MDR expectations and where the EU AI Act applicable for AI-enabled medical device software

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Target Audience: Software engineers, architects, systems engineers, testers, and project managers in medical device software development, regulatory affairs, quality management, risk, audit, cybersecurity and documentation professionals. Teams preparing or reviewing software documentation for MDR compliance and Notified Body submissions. Applicable to embedded, standalone, health, and AI-enabled medical device software. Suitable for beginners and experienced professionals working with IEC 62304 and IEC 82304-1. Basic knowledge of medical device development, QMS, risk management, or software engineering is beneficial