Join us for MedDev Day Virtual 2020 on 22nd September! During this second edition of the MedDev Day industry experts will share their experience and real-life examples on how to reach the MDR compliance.
The event will address topics such as:
- The EU perspective: Latest developments in MDR implementation regulations, Common Specifications and Clinical Guidance Documents
- The notified body perspective: notified body experiences on audits on Medical Devices Quality Management System readiness, and MDR product certification. Lessons learned from past audits including remote audit situation
- The industry perspective: how to use the remaining months for MDR readiness and MDD projects
- Discussions on Common Specifications (CS) for MDR Annex XVI devices without medical purpose. Impact of CS on planning sufficient clinical data
- The role of the person responsible for regulatory compliance (PRRC) in the clinical strategy and investigational devices. Liability and risk mitigation
- How to assess and close gaps in clinical evidence. Challenges in the clinical evaluation and investigation route. The role of post market surveillance clinical data
- Practical Medical Devices clinical evaluation plans and clinical evaluation documentation per device risk class:
- Clinical evaluation plans and clinical investigation plans for class I, II and III products in line with the revised ISO 14155
- Post market clinical follow up (PMCF) plans and reports for class I, II and III products
- Post market surveillance (PMS) documentation, periodic safety update reports (PSURS) and summary of safety and performance characteristics (SSCP) how and what to compile for each device class
We have the pleasure of joining MedDev Day 2020 as sponsors.
- Date: 22nd September
- Place: online
- Agenda: available here
Join us for MedDev Day Virtual 2020! Contact us if you would like to learn more about our Medical Device services. Our experts will be glad to answer your questions.