Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) of Medical Devices
Implement market surveillance of medical devices with PMS and PMCF
Stay ahead in the medical device industry by mastering the essentials of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF). Our 1-day training course is designed to help you navigate the complexities of the Medical Device Regulation (MDR, 2017/745) and ensure your products meet the highest standards of safety and performance.
This training provides a comprehensive overview of the legal requirements of the MDR for PMS/PMCF, emphasizing the importance of vigilance in market observation. You will gain practical knowledge on implementing PMS/PMCF requirements within your company, ensuring your products remain safe and high-performing.
Join us for this essential 1-day training course to ensure your organization is fully compliant with PMS and PMCF requirements. Enhance your knowledge and skills to maintain the safety and performance of your medical devices. Enroll today and take the first step towards mastering post-market surveillance!
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This course is ideal for professionals involved in the medical device industry, including:
- Quality Assurance Managers
- Regulatory Affairs Specialists
- Clinical Affairs Professionals
- Product Managers
- Project Managers
- Medical Device Industry Consultants
- Service Providers for Clinical Trials with Medical Devices
The following key topics are covered in this training:
- Requirements for PMS/PMCF According to the MDR: Understand the specific requirements and how to implement them.
- Role of PMS and PMCF in the Product Life Cycle: Learn how PMS and PMCF fit into the overall life cycle of medical devices.
- Role of Economic Actors in PMS: Explore the responsibilities of various stakeholders in the PMS process.
- Importance of Vigilance: Recognize the critical role of vigilance in ensuring ongoing product safety and performance.
- Implementation of PMS/PMCF Requirements: Gain insights into practical implementation strategies within your organization.
- Documentation Requirements: Understand the necessary documentation for compliance with PMS/PMCF.
- MDR Requirements for Authorities and Notified Bodies: Learn about the regulatory expectations and how to meet them.
PMS and PMCF are critical components of market surveillance, required to monitor residual risks, identify new risks, and verify the performance of medical devices post-market launch. The MDR introduces numerous additions and innovations that manufacturers must implement for effective market surveillance. This course will guide you through these requirements, ensuring you understand how to comply with PMS/PMCF strategies and their documentation, as monitored by Notified Bodies.
By participating in this training course, you will:
- Understand Legal Requirements: Receive a compact overview of the MDR requirements for PMS/PMCF.
- Enhance Vigilance: Gain a deeper understanding of the importance of vigilance in market surveillance.
- Implement PMS/PMCF: Acquire practical knowledge on how to implement PMS/PMCF requirements in your company.
- Optimize Compliance: Ensure your company meets the regulatory standards for market surveillance.
- Instructor-led in a virtual classroom
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognized TÜV SÜD certificate upon completion
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Participants in this training receive a Certificate of Attendance by TUV SUD Academy.