All business processes of a medical technology company are subject to a risk-based approach. Accordingly, risk management is one of the most important tasks. It accompanies the complete life cycle of a medical device, from the first drafts to post-market surveillance.

The certificate course shows the framework conditions of risk management, imparts practice-oriented knowledge and thus enables the requirements of standards and EU-MDR to be implemented professionally. Examples illustrate how processes should be set up to implement and maintain an effective system. On the last day of the seminar, the focus will be on practical examples, both for risk management and for risk analyzes and assessments.

target group

Employees from quality management who are responsible for the implementation and implementation of risk management in a medical technology company or who provide administrative support to the management.

Topic overview & dates


Risk management process according to ISO 14971 | Risk-based approach to all business processes | Qualifications of staff | General basic safety and performance requirements according to EU-MDR, Annex I


Post Market Clinical Follow-up (PMCF) – Market Observation | Reporting incidents and safety information - conducting recalls | Complaints management


FMEA | Risk analysis – identification of hazards | Risk Management Plan | Risk Management Report | risk management file


Identification and traceability | Control of non-conforming products | CAPA system | 8D report


Practical examples of risk management, risk analyzes and assessments | PMS and trending

exam and graduation

After the course, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After passing the exam, the participants receive a certificate issued by MedicalMountains GmbH.

Funding Opportunity

Tuttlingen & Online


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