Qserve MedTech Pre-Conference Workshop

Real-world data (RWD) is rapidly reshaping how MedTech and IVD companies generate clinical evidence and demonstrate value. But without a clear strategy, RWD initiatives often fall short of regulatory and business expectations.

This half-day workshop focuses on building a robust, future-proof RWD strategy aligned with regulatory requirements and organizational goals. You will explore how to position RWD within your clinical, regulatory, and market access strategies, and how to determine when and where it adds the most value.

With practical insights, including IVD-specific considerations, this session bridges high-level strategy with real-world application, helping you make informed, impactful decisions.

A strong foundation in design controls is essential for successful regulatory approval. This half-day workshop combines three critical elements, design controls, intended purpose and claims, and the implementation of an electronic Quality Management System (eQMS).

You will learn how to define intended purpose and indications for use in a way that supports regulatory strategy and avoids costly delays. The session also covers how to structure design control processes in line with regulatory expectations, and how an eQMS can streamline documentation, traceability, and collaboration.

Practical examples will demonstrate how these elements are interconnected and how to implement them effectively in your organization.

Agile methodologies promise speed, adaptability, and continuous improvement, but how do you apply them in a highly regulated MedTech environment without compromising compliance? This interactive session bridges the gap between Agile principles and regulatory expectations for medical device and IVD software development.

You will explore how to align Agile workflows with standards such as IEC 62304, ISO 13485, and evolving regulatory frameworks, while maintaining traceability, documentation, and risk control. Through practical examples and real-world scenarios, we demonstrate how Agile can strengthen, not weaken, your compliant development process.

By the end of this full-day session, you will understand how to structure Agile teams, documentation, and validation activities in a way that satisfies both auditors and developers.

The FDA’s transition from 21 CFR Part 820 to the Quality Management System Regulation (QMSR) marks a significant shift for MedTech companies. This half-day workshop helps you understand what is changing, what remains the same, and how to prepare.

You will explore how QMSR aligns with ISO 13485 and what this means for your existing quality system. The session provides practical guidance on gap assessments, implementation strategies, and maintaining compliance during the transition period.

Real-world insights will help you confidently adapt your processes and ensure readiness for FDA inspections.

Real-world data (RWD) is becoming a cornerstone of clinical and regulatory strategies in MedTech. This half-day workshop focuses on the practical implementation of RWD for Post-Market Clinical Follow-up (PMCF) and registry-based studies.

You will learn how to design, collect, and use real-world data to generate meaningful clinical evidence that meets regulatory expectations. The session covers data sources, study design, governance, and integration into your clinical and regulatory strategy.

Through practical examples, you will gain insights into overcoming common challenges and ensuring data quality and compliance.

With the latest updates to ISO 10993-1:2025, biocompatibility evaluation continues to evolve, requiring a more risk-based and strategic approach. This half-day workshop provides a clear and practical overview of the new requirements and their impact on medical device development.

You will learn how to plan, assess, and document biocompatibility in line with the updated standard, including when testing is required and when a justification-based approach is sufficient.

Through case studies, the session will highlight common challenges and how to address them effectively, ensuring compliance while avoiding unnecessary testing.

Data security is no longer optional in MedTech, it is a regulatory and business-critical requirement. This half-day workshop provides a practical approach to implementing robust data security measures across the lifecycle of medical device and IVD software.

You will gain insight into key requirements from regulations and standards such as MDR, IVDR, GDPR, and relevant cybersecurity guidance. The session translates these requirements into actionable steps, covering risk management, secure design, data protection, and incident response.

Through real-world examples, you will learn how to embed data security into your QMS and product development processes without slowing innovation.