ICPMSB Certified Professional for Medical Software - Foundation Level (CPMS-FL)
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.
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Description
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.
What You Will Learn
The Certified Professional for Medical Software – Foundation Level consists of six modules, as defined in the official curriculum.
Part 1 – Regulatory Basics
Covers the essential legal and normative requirements for medical software.
Part 2 – Risk Management
Introduces the fundamental principles of risk handling in medical software.
Part 3 – Software Engineering
Provides the core engineering concepts relevant to developing medical software.
Part 4 – Usability
Explains the foundational aspects of usability for medical software and devices.
Part 5 – Quality and Document Management
Covers quality assurance processes and documentation requirements.
Part 6 – Medical Informatics
Introduces the basics of medical informatics as relevant to software development.
Certification & Exam
After completing the CPMS-FL training, you can take the official Foundation Level exam. The exam consists of 32 questions, must be completed within 60 minutes, and requires a minimum score of 60 percent to pass. The questions cover all six modules of the CPMS curriculum, including regulatory basics, risk management, software engineering, usability, quality and document management, and medical informatics.
There are no formal prerequisites for the exam, which makes the certification accessible to anyone working with or entering the field of medical software. Once you pass, you receive the CPMS Foundation Level certificate, confirming that you understand the essential principles and regulatory expectations for developing safe and compliant medical software.
What You Will Achieve
By the end of the course, you will be able to:
understand the key regulatory requirements that apply to medical software and how they influence development
apply basic risk management principles to identify, assess and document risks in medical software projects
explain core software engineering practices within the context of regulated medical environments
recognise the importance of usability engineering and how it supports safe and effective use of medical devices
understand the role of quality management and required documentation throughout the software lifecycle
use essential concepts from medical informatics to interpret and work with medical data within software systems
Training Providers
No providers available for this course yet.
FAQs
CPMS Foundation Level is a certification focused on medical software development basics. It explains how medical software is developed, validated, and maintained under regulatory and quality requirements.
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