Against the backdrop of increasingly stringent global medical device regulatory frameworks — particularly the full rollout of the EU Medical Device Regulation (MDR) and the updated biocompatibility assessment standard ISO 10993-1:2025 — manufacturers are confronted with unprecedented compliance challenges.
From rigorous clinical evaluation and intricate chemical characterisation to the growing prominence of cybersecurity risks, precisely aligning with evolving regulatory requirements and establishing an efficient safety assessment system has become a critical priority for medical device enterprises pursuing overseas expansion and high-quality development.
Against this backdrop, Applus+ Laboratories, in partnership with Desheng Testing, will co-host the "Seminar on EU Medical Device Regulation Compliance and Safety Assessment Technologies" in Jinan on 24 July 2026. The event will deliver highly practical compliance upgrade roadmaps and tailored solutions for participating manufacturers, empowering them to forge steady progress amid fierce market competition.
Date:
Friday, 24 July 2026
Venue:
Hampton by Hilton Jinan Railway Station, Jinan City, Shandong Province
Agenda:
8:30-8:55: Registration
9:00-9:05: Opening Remarks
9:05-10:05: ISO 10993-1:2025 key Changes in Biological Safety Evaluation and Effective Upgrade Pathways for Entrprises
10:30-11:30: EU Medical Device Regulation (MDR) CE Compliance Strategy
13:30-14:30: Key Points of Chemical Characterization Testing for Medical Devices and Case Studies
14:50-15:50: MDR (CE) Cybersecurity Project Case Studies and Testing Analysis
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