The International CPMS Board e.V. (ICPMSB) is an international consortium of experts in the field of medical software.
The Advanced Level – Process Management track extends the foundational CPMS syllabus. It deepens your knowledge and skills around process design, regulatory affairs and quality management for medical-software projects. This track is meant for professionals who must handle the lifecycle, regulatory compliance and organisational aspects of software-as-medical-device development, beyond purely coding or testing tasks.
The Advanced Level – Software Development track expands the foundational CPMS knowledge with a deeper focus on engineering practices for medical software. It covers the technical, architectural and lifecycle-related aspects required to build safe, effective and regulation-compliant software systems. The course is designed for professionals involved in software design, implementation, verification and maintenance within medically regulated environments. Its aim is to ensure that engineers can apply the required standards, methods and documentation practices throughout the entire development process.
The CPMS-FL program trains you in the essentials required for developing, testing, and managing medical software. You learn regulatory basics, risk management, software engineering practices, usability, quality and document management, and medical informatics. The course gives you a broad foundation covering both the technical and regulatory aspects needed to produce safe and compliant medical software.CPMS-FL is suitable for software developers, quality managers, regulatory officers, project managers or anyone working with medical software products. The certification helps you understand legal standards, risk processes, usability requirements and quality controls specific to medical software development.
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The CPMS Foundation Level comprises six consecutive modules about the topics:
1. Regulatory basics
2. Risk management
3. Software engineering
4. Usability
5. Quality and document management
6. Medical informatics
The initiative “Certified Professional for Medical Software” (CPMS) aims at the following goals:
- To establish a focussed education for professionals in and around the field of medical software
- To achieve a common educational background for the target groups
- To promote and raise awareness for the occupational profile of medical software development
ICPMSB offers a structured certification system for professionals working with medical software. The certificates focus on safety, regulation, quality and engineering practices in the medical-device environment.
This is the starting point for everyone.
You learn the fundamentals of medical-software development: regulatory basics, quality and risk management, usability, documentation, software engineering and IT-security requirements.
After your preparation, you take the Foundation exam. When you pass, you receive the CPMS-F certificate, which proves your understanding of essential medical-software standards.
With the Foundation certificate, you can specialise in one of two advanced paths:
Advanced Process Management (AL-PM)
Focus on regulatory processes, quality management, documentation, usability engineering and risk control.
Advanced Software Development (AL-SW)
Focus on lifecycle models, design for safety, testing, maintenance and technical requirements for medical-software development.
Each advanced path ends with its own exam and certificate.
By combining Foundation and Advanced certifications, you build a recognised qualification for roles in regulatory affairs, medical-software engineering, quality management, usability and compliance.
CPMS Foundation → choose Advanced path (Process or Software) → pass exams → build your certified profile in medical-software development
