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Mercure Hotel MOA Berlin, Berlin, Germany,
Hybrid Event I Attend In-Person or Digitally
18 - 19 June 2025
Clinical Evaluations, Investigations and Performance Evaluations
Determine Desirable Data. Sufficiently Support Claims. Streamline Clinical Processes.
Master Clinical Compliance Under the EU MDR & IVDR
Get the latest clinical evidence and performance evidence updates, straight from the regulators
Explore the latest clinical evidence updates from the Austrian Competent Authority, AGES
Navigate the unique challenges of combined trials with feedback from Bayer, AGES and FAMHP
Apply the lessons learnt from piloting coordinated assessments and performance studies with FAMHP
Maximise your clinical data to successfully support claims
Get insight into current Notified Body alignment on clinical expectations and industry feedback in our multi-stakeholder panel
Establish state of the art expectations and put your device at the forefront with a robust clinical evaluation plan
Harness the power of AI to streamline clinical and performance evaluation documentation and enhance team efficiency
Deepen your knowledge of the increasingly stringent clinical requirements
Dive into the latest MDCG guidance on Orphan Devices and unlock the secrets to successful application
Build a clear picture of when and how to collect data for devices without an intended medical purpose
Identify the latest global acceptance levels of real-world evidence through experiences from industry
Meet The Experts Pioneering Clinical Best Practice
SME Survival Guide Workshop
Monday 16 June
- Understand the EU regulatory landscape for innovation
- Identify key stakeholders to bring devices and IVDs to market
- Curate effective regulatory and clinical strategies
- Develop and complete technical files for submission
- Pinpoint funding pathways and develop pitches
- Navigate pricing and reimbursement options
