Certified Professional for Medical Software (CPMS) – Foundation Level

Overview

Software Quality Assurance

1.800,00 € per participant plus VAT

10/20/2026 - 10/23/2026

German

Online (live online training)

215,00 € Examination fee per participant plus VAT

Book now Inhouse-request

Your contact

Stephanie Kaiser
sepp.med academy

+49 9195 931–234

Everything important at a glance

What is the aim of the CPMS Foundation Level training?

The Certified Professional for Medical Software (CPMS) training course teaches the essential basics for the development, quality assurance and management of medical software. This training optimally prepares you for the CPMS certification, which is internationally recognized as the standard in medical technology. Participants benefit from practical exercises and in-depth knowledge that is specifically geared towards the requirements of regulatory compliance and software quality in medical technology.

After the course, participants will be able to:

Understand and apply the regulatory requirements (e.g. MDR, ISO 14971, IEC 62304).
Effectively plan and implement risk management processes.
Develop high-quality medical software in accordance with current standards.
Develop strategies to ensure usability and IT security.
Design efficient quality and documentation management.

Course content: What you will learn

Regulatory requirements for medical software:

Introduction to MDR, IEC 62304, ISO 14971 and other relevant standards.
Importance of conformity and certification in medical technology.

Risk management:

Identification and evaluation of risks in software development.
Development of effective risk mitigation measures.

Software engineering:

Agile and classic methods for developing medical software.
Test procedures and their integration into the development process.

Usability and user centricity:

Designing user-friendly software and intuitive user interfaces.
Implementation of IEC 62366 requirements for usability engineering.

Quality and documentation management:

Creation of technical files and development documentation.
Strategies for compliance with legal requirements.

IT security:

Introduction to security requirements and data protection (GDPR).
Measures to protect sensitive medical data.

Medical informatics:

Integration and processing of medical data.
Standards such as HL7 and FHIR in practice.

The CPMS certification

After completing the course, participants can take the Certified Professional for Medical Software - Foundation Level exam. This internationally recognized certificate will improve your career prospects and make you stand out on the job market.

Benefits of CPMS training

Increasing your expertise in medical software development.
Ensuring regulatory compliance in your projects.
Improving software quality and usability.
International recognition through a renowned certificate.
Career advantages in a rapidly growing industry.

Details of the CPMS course

Prerequisites: Basic knowledge of software development and initial experience with medical devices are an advantage, but not a prerequisite.
Certificate: Participants will receive a certificate of attendance.

Target group

The CPMS training is aimed at:

Software developers, architects and designers in the field of medical technology.
Test managers and quality managers.
Regulatory Affairs Manager.
Project managers and product managers.
Employees of supervisory authorities and certification bodies.

Why CPMS?

The development of medical software is subject to strict regulatory requirements and presents developers with complex challenges. The CPMS certification qualifies you for this demanding industry and gives you the skills you need to develop software that meets the highest quality and safety standards.