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.

Selecting the appropriate FDA regulatory pathway is one of the most critical strategic decisions for medical device manufacturers entering the US market. This half-day workshop provides a practical guide to understanding and navigating FDA pathways, including 510(k), De Novo, PMA, Humanitarian Device Exemption (HDE), and Breakthrough Device Designation.

You will learn how to evaluate device characteristics, risk classification, predicate availability, and clinical evidence requirements to determine the most suitable regulatory route. Gain the knowledge and tools needed to develop an effective FDA regulatory strategy, reduce uncertainty, and accelerate market access for medical devices.

Through practical examples and case-based discussions, the workshop will address common decision points, regulatory challenges, and strategies to optimize submission planning.

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.

Bringing breakthrough medical technologies to market requires more than innovative science, it demands a clear regulatory strategy. This half-day workshop provides a practical overview of the regulatory pathways, strategic considerations, and best practices for accelerating breakthrough medical devices in both the EU and the USA.

You will learn how to define an innovation strategy, navigate evolving regulatory frameworks, engage effectively with regulatory authorities, and build evidence packages that support market access. Discover how to identify regulatory opportunities, avoid common pitfalls, and develop a roadmap for successfully bringing innovative medical devices to patients.

Real-world examples will illustrate the similarities and differences between the EU and U.S. regulatory approaches, including the EU MDR innovation landscape and the FDA Breakthrough Devices Program.