Date:
15 - 18 June 2026
Language:
Location:
Abstract:
The MedTech Summit 2026, organized by Informa Connect, is a leading European conference dedicated to regulatory excellence and innovation in the medical device industry. Held in Berlin, the event brings together regulators, notified bodies and industry leaders to address the evolving landscape of medical device compliance and patient safety.
The multi-day program features expert-led sessions, workshops and roundtables covering key topics such as EU MDR, clinical evaluations, post-market surveillance and Software as a Medical Device (SaMD) including AI.
Attendees gain practical insights into navigating regulatory requirements, accelerating market access and ensuring product safety across global markets.
With its strong focus on knowledge exchange and real-world application, the summit provides a platform for professionals to stay up to date with industry trends and regulatory developments.
In addition to its comprehensive agenda, the event offers extensive networking opportunities, enabling participants to connect with peers, experts and key decision-makers across the MedTech ecosystem.
More details about the event can be found here.
Our Presentation:
Title: How To Connect Software Development and QARA Teams?
Speaker: Christophe Girardey
Abstract:
- Rapid growth of software in medical devices is exposing a critical gap between Software Development (Agile, CI/CD, automated testing, modern tools) and Quality & Regulatory Affairs expectations aligned with IEC 62304, leading to misunderstandings and inefficiencies.
- Differing mindsets, developers viewing documentation as a burden and QARA teams expecting traditional, document-heavy compliance, often create redundancy, inconsistencies and misalignment between "official" documentation and the actual software state.
- Christophe will share practical strategies to successfully bridge this gap by aligning modern development practices with regulatory compliance and integrating Quality by Design principles into everyday workflows.
For us on site:
Christophe Girardey
Managing Director and Head of the CSV & QA department at wega Informatik AG.
He works as a CSV consulting expert in many different projects, mainly in German-speaking countries.
He has a particular focus on laboratory data systems (LIMS, chromatography data systems, laboratory execution systems) and supports customers in implementing the best solution from various perspectives (efficiency, compliance, data integrity).
He also supports many customers in the optimal use of the agile methodology in the GxP environment.