Basic seminar on risk management – Module 1
Description
At the heart of the legal requirements for medical devices in Europe are the fundamental safety and performance requirements (previously known as essential requirements) that must be met by all medical devices. As a basis, they require a risk management system that covers all phases of the product life cycle to be implemented by the company. The prospective identification and assessment of risks is part of the development and initial market launch phases; during the marketing phase, this is done retrospectively through post-market surveillance and vigilance. Essential risk management content is also included in the reports for post-market surveillance, which are now required by law.
The basic seminar on risk management (Module 1) explains consistent, practical processes and methods for implementing risk management while taking into account the applicable standard EN ISO 14971.
The advanced seminar in the form of a workshop (Module 2) expands on previous knowledge using practical examples of risk analysis, which relate to product use, design and manufacturing processes. Module 2 also goes into more detail on how the results of risk analysis can be reincorporated into the development, design verification and product validation processes. Module 2 can only be booked together with the Module 1 basic seminar.
Contact Person
Goals
The basic seminar explains the basics of risk management for medical devices and the process of performing risk analyses in line with the requirements set out in laws and standards. It is based on the applicable legal requirements and the EN ISO 14971 standard in its current form. The seminar explains how to design and implement a comprehensive risk management process.
Seminar content
- Overview of the legal requirements for safety and minimising risks with respect to medical devices
- Structure and composition of EN ISO 14971
- Structure of a risk management file
- Creation of a risk management plan
- Hazards (hazard list) and their assessment, risk assessment
- Procedures in risk analysis (performance, form, report, requirements for documentation) and measures for minimising risks
- Risk assessment during the different product life cycles
- Integrating the risk management process into the quality management system
- Practical examples
Target group / seminar duration and certificate
This seminar is suitable for members of risk management teams and staff who assess the results of risk management, such as internal auditors, product managers, developers and regulatory affairs staff.
The content is presented over the course of a one-day seminar. There is also the option to book Module 2 (also presented over the course of a one-day seminar) to expand on the topic. The participants receive a certificate of attendance and, on request, materials for participants in physical or digital form.
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