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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
03/28/2023 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
03/29/2023 Post Market Clinical Follow-up (PMCF) – Market Observation | Incident Reporting and Safety Information - Conducting Recalls | complaint management
04/25/2023 FMEA | Risk analysis – identification of hazards | Risk Management Plan | Risk Management Report | Risk Management File | if necessary, further risks arising from risk control measures
04/26/2023 Identification and traceability | Control of non-conforming products | CAPA system | 8D report | risk mitigation and risk control
04/27/2023 Practical examples of risk management, risk analyzes and assessments | PMS and trending
Test.
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 participant receives a certificate issued by MedicalMountains GmbH.
Funding Opportunity
ESF funding is possible. More information can be found here .
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
