Training
ICPMSB® Advanced Level – Software Development (AL-SW)
- Advanced
Description
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.
Course Content
The Advanced Level – Software Development curriculum covers the core engineering disciplines required for developing medical software in a regulated environment. It extends the foundational knowledge with deeper technical, methodological and lifecycle-oriented competencies.
Part 1 – Software Requirements and Architecture
You learn how requirements and architecture must be defined, structured and documented to comply with medical-software standards and safety expectations.
Part 2 – Software Design and Implementation
This part focuses on designing software components, applying appropriate design methods and implementing solutions that fulfil regulatory and quality-system criteria.
Part 3 – Verification and Validation of Medical Software
You learn how verification and validation activities must be planned, executed and documented, including test strategies, traceability and evidence generation for regulatory purposes.
Part 4 – Configuration and Change Management
You understand how configuration control, change processes and versioning must be handled to ensure traceability and maintain compliance across the entire lifecycle.
Part 5 – Software Maintenance and Lifecycle Activities
This section covers maintenance responsibilities, defect handling, updates, post-market considerations and lifecycle documentation for medical software.
Sessions to Enroll
No sessions available.
Certification
After completing the AL-SW training, you can take the official Advanced Level – Software Development certification exam. The exam evaluates whether you can apply the engineering-focused learning objectives defined in the CPMS curriculum, including requirements, architecture, design, implementation, verification, validation, configuration management and lifecycle processes.
The exam is based entirely on the Advanced Level syllabus and tests your ability to understand and apply the regulatory, methodological and technical principles required for developing medical software in compliance with international standards.
There are no additional formal prerequisites beyond the expectation that candidates have completed the CPMS Foundation Level and have practical experience in medical-software projects. After passing the exam, you receive the CPMS Advanced Level – Software Development certificate, confirming your competence in engineering safe, traceable and regulation-compliant medical software across its full lifecycle.
Outcome
By the end of the course, you will be able to:
understand how regulatory and safety requirements influence software engineering decisions in medical-device development
translate requirements into compliant software architectures and design structures that support traceability and risk control
apply design and implementation practices that meet quality-system expectations and documentation obligations
plan and perform verification and validation activities that provide the required evidence for regulatory conformity
establish configuration and change-management processes that ensure full traceability throughout the software lifecycle
manage maintenance tasks, updates and defect handling in a way that supports ongoing compliance and patient safety