Date: 10 December 2026
Time: 16:00 - 17:00 CET | 10:00 - 11:00 am EDT
Location: Virtual
Introduction
The post-market and clinical investigation landscape continues to evolve, and understanding the latest expectations under MDR and ISO 14155 is essential for medical device manufacturers planning, conducting, or maintaining clinical investigations.
Join Qserve CRO and TransPerfect for a live, free webinar exploring the key “lessons learned” in implementing new MDR post-market requirements as well as ISO 14155 updates and what they mean in practice for clinical investigations in 2026.
The webinar will combine perspectives from both the post-market and clinical investigation environments, providing attendees with practical insights into how evolving expectations can affect post-market documentation, in addition to clinical investigation planning, conduct, documentation, data, and overall regulatory strategy.
TransPerfect will share the post-market perspective, including key learnings and considerations regarding SSCPs and SSPs. Qserve CRO will then explore the 2026 ISO 14155 updates and their potential impact on clinical investigations, followed by a live Q&A session where attendees can ask questions directly to the experts.
Whether you are currently planning a clinical investigation, managing an ongoing study, or looking to strengthen your clinical and post-market strategy, this webinar will provide practical considerations to help you prepare for the evolving requirements.
The session features a 45-minute informal presentation followed by a live Q&A. You can submit your questions through the registration form, by email at marketing@qservegroup.com, or directly during the event.
Agenda:
- Welcome & Introduction (5 min)
- The TransPerfect Post-Market Perspective (10 min)
- Post-market documentation: SSCPs and SSPs
- A risk-based approach to SSCPs and SSPs
- Implications for compliance
- ISO 14155 Updates in 2026: What You Need to Know (45 min)
- Overview of ISO 14155 and its role in clinical investigations of medical devices
- Key updates and areas of change in 2026
- Why these changes matter for manufacturers and clinical investigation teams
- Key Learnings and Practical Impact
- Live Q&A (15 min).
Learning Objectives:
By attending this webinar, participants will:
- Define an effective strategy for managing SSCP and SSP content.
- Understand the key ISO 14155 updates and developments relevant to clinical investigations in 2026.
- Identify how the updated expectations may impact the planning, design, conduct, and documentation of clinical investigations.
- Recognize the relationship between clinical investigation activities and post-market evidence generation.
- Identify practical considerations for adapting clinical investigation strategies and processes to evolving ISO 14155 expectations.
- Apply key learnings from industry and post-market experience to strengthen their clinical evidence strategy.
- Recognize areas where early planning and proactive assessment can help reduce challenges during clinical investigations.
Who should attend?
This webinar is intended for professionals involved in the development, clinical evaluation, regulatory strategy, and post-market activities of medical devices, including:
- Clinical Affairs and Clinical Research professionals
- Clinical Project Managers
- Regulatory Affairs professionals
- Medical Affairs professionals
- Post-Market Surveillance professionals
- Quality Assurance professionals
- Medical device manufacturers and sponsors
- Investigators and clinical research teams
- Consultants and service providers supporting clinical investigations
- Professionals responsible for clinical evidence and clinical strategy.
The webinar is particularly relevant for organizations that are planning a new clinical investigation, conducting an ongoing investigation, or reviewing their clinical evidence and post-market strategy in light of the 2026 ISO 14155 updates.