Expert in regulatory requirements for Medical Devices
Description:
- Ability to understand key regulatory requirements and standards.
- Ability to acquisition of practical knowledge for implementing legal requirements into daily processes.
- Ability to ensure compliance with legislative requirements for importers and distributors of Medical Devices.
- Ability to effectively manage quality and traceability of Medical Devices
- Ability to fulfilling post-market surveillance obligations.
- Ability to identify processes, to create a process model, to monitor and control processes
- Ability to address risks and opportunities
- Ability to determine requirements (e.g., from customers, legal requirements, internal requirements)
- Ability to plan inspection activities and sampling
Previous skills/knowledge: - Basic knowledge of Quality or Medical Devices Management Systems and its methods and tools (targeted at operational staff, top managers, group leaders and department managers from all areas).
- Professional experience, including Medical Devices Management Systems (recommended).
- Professional experience, including Medical Devices Management Systems (recommended).
Authorized Partners:
Teaching requirements:
- Trainer work-experience in the area of Medical Devices Management System.
- Trainer should be a qualified Lead Auditor
Objectives to achieve: To get the necessary knowledge and skills to:
- To be able to apply the most important methods and tools in the area of Medical Devices Management Systems
- To be able to understand the basic normative requirements of Regulation (EU) 2017/745 and ISO 13485
