Gain a better understanding of responsibilities and interfaces
Are you a recent college graduate or someone new to the medical device industry, but unsure of the tasks and responsibilities that lie ahead?
Are you working in a specialized department (e.g., PMS) and performing your duties conscientiously, but unsure how other departments are affected by your work or what they do with the documents you create? Perhaps thereare occasional conflicts between departments?
Anyone working in the medical device industry should know and understand the big picture. Daily work is based on the requirements of the Medical Devices Regulation (EU) 2017/745 (MDR). This new regulation brings with ita whole range of tasks and obligations for medical device manufacturers and other economic operators. It is not only helpful to know the responsibilities and interfaces between economic operators, but also between the specialized departments within an organization.
In this interactive training, you will learn about the various requirements and interfaces in medical technology and, using hands-on examples, discover how to effectively implement these requirements.
- Content
- Key Terms under Article 2 of the MDR
- Authorization of Medical Devices
- CE Marking
- Classification of Medical Devices
- EU Conformity Assessment Procedures and Declaration of Conformity (DoC)
- General obligations of manufacturers
- MDR Article 10
- General safety and performance requirements
- Risk management
- Technical documentation
- Post-market surveillance (PMS) system
- Article 32: Summary of safety and clinical performance (SSCP)
- MDR Article 15
- Person responsible for regulatory compliance (PRRC)
- Vigilance
- Article 87: Reporting of serious incidents and field safety corrective actions
- Article 88: Trend reporting
- Other economic operators and registration obligations
- Authorized representative, importer, and distributor
- EUDAMED
- Your Benefits
- You’ll gain an up-to-date overview of regulatory requirements and the standards of the medical technology industry.
- You’ll acquire a comprehensive foundation of knowledge to help you establish yourself in the medical device industry.
- You’ll understand the relationships and interactions between different departments and grasp the big picture.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Professionals or career changers
- Regulatory affairs specialists
- Quality management specialists
- Employees from various departments who want to better understand the big picture and the interfaces with other departments
