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Whitepapers
- Qualification & Validation
New GMP Facility Qualification: Set-up, Process and Best Practices
- Clinical
State-of-the-art literature review: Kick Off the Clinical Evaluation of your Medical Device
- Software Solutions & Services
GAMP categories for computerized systems: what are they and what are they for?
- ATMP
Cell by Design: Why a practical framework is key to the R&D process of any cell-based ATMP
- ATMP
Analytical method validation: A validated process control method to determine cell density
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Webinar on demand - Mastering Clinical Performance Studies under IVDR
Webinar on demand - From Paper to Practice: Technical Documentation Essentials for Medical Device Software
Webinar on demand - Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation
Webinar on demand - From Requirements to Code: Streamlining Your Medical Device Software Development Cycle
Webinar on demand - From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software
Webinar on demand - Getting Started: Overcoming Initial Obstacles in Medical Device Software Development
Standards and regulations for Software used in Medical Devices
GAMP 5 Software Validation Approach for GMP, GCP, and GLP regulations