ICPMSB® Advanced Level – Process Management (AL-PM)
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.
Description
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.
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What You Will Learn
The AL-PM curriculum covers these main domains:
Regulatory fundamentals and medical-device legislation (standards, harmonised norms, classification, regulatory roles)
Process design and quality management for medical-device software (incl. documentation, compliance to norms, quality-system alignment)
Risk management and lifecycle-wide risk control for medical software (maintenance, post-market surveillance, conformity assessment, roles & responsibilities)
IT security and data protection aspects where applicable for medical software when required under regulation.
Each of these domains is structured with defined learning objectives, including knowledge of relevant standards and ability to apply process and quality requirements.
Certification & Exam
After completing the Advanced Level – Process Management training, you can take the official AL-PM certification exam. The exam evaluates whether you can apply the regulatory, organisational and process-related knowledge defined in the Advanced Level curriculum.
The assessment is based on the learning objectives in the curriculum, including regulatory frameworks, process design, quality-management responsibilities, lifecycle activities and risk-management practices for medical software. The exam ensures that candidates can interpret requirements, analyse process structures and understand how regulatory rules translate into practical process decisions.
There are no additional formal prerequisites, but candidates are expected to have completed the CPMS Foundation Level and to have practical experience in medical-software projects. Once you pass the exam, you receive the CPMS Advanced Level – Process Management certificate, confirming your ability to design, manage and evaluate processes for compliant medical-software development.
What You Will Achieve
By the end of the course, you will be able to:
understand how medical-device regulations and standards influence software-development processes
design and evaluate development processes that meet regulatory and quality-management requirements
apply risk-management principles across the entire software lifecycle, including maintenance and post-market activities
interpret regulatory expectations and translate them into practical process steps and documentation requirements
understand organisational roles and responsibilities needed for compliant medical-software development
assess process quality and identify improvements that support safety, traceability and regulatory conformity
Training Providers
No providers available for this course yet.
FAQs
AL-PM is an advanced certification for process management in medical software development. It focuses on defining, managing, and improving processes across the medical software lifecycle under regulatory requirements.
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