IEC 62304 is the internationally recognized standard for the development and maintenance of software used in medical devices. It defines detailed requirements for the entire software lifecycle – from development to risk and configuration management, maintenance, and problem resolution. Special emphasis is placed on integrating risk management (in accordance with ISO 14971) and ensuring safety-related processes based on software safety classes (A, B, C).

IEC 62304 Coaching & Consulting Services:

• Process-Oriented Introduction to IEC 62304:
  Comprehensive introduction to all standard requirements, tailored to your specific development environment – applicable to both embedded systems and standalone medical software.
• Optimization of Development and Lifecycle Processes:
  Support with implementing, documenting, and continuously improving all software lifecycle processes – from initial requirements to maintenance and CAPA (Corrective and Preventive Action).
• Integration of Risk Management:
  Setup and execution of compliant risk analyses in accordance with IEC 62304 and ISO 14971, including links to Usability Engineering (IEC 62366) and Electrical Safety (IEC 60601).
• Coaching for Regulatory Requirements:
  Preparation for and support during authority or client inspections, assistance in creating IEC 62304-compliant audit documents and declarations of conformity.
• Hands-on Support for Agility, Tools, and AI-based Software:
  Guidance on introducing agile development processes, integration of tools (e.g. Jira, Jama), and support for AI-based software according to the latest regulatory interpretations.
• Workshops and Team Trainings:
  Customized trainings and practical team workshops on fundamentals, implementation, best practices, and daily challenges in applying IEC 62304.

Who is this coaching for?
This offer is designed for development teams, quality management, regulatory affairs, project managers, and those responsible for medical software – whether for traditional medical devices or standalone software (SaMD).

Objective:
After the coaching, you will understand the regulatory requirements of IEC 62304, be able to implement them efficiently within your organization, meet compliance expectations, and sustainably optimize your development processes.

For tailored advice or customized IEC 62304 coaching, feel free to get in touch.