Attend this collaborative event with rich content with two tracks addressing key issues for the design & development and manufacturing environments, including:
Compliance Intelligence – SaMD, CSA, EU MDR, 21 CFR 820, Annex 11
• Supplier Qualification and Management
• Bridging the Gap Between R&D and Manufacturing
• CSV to CSA Transition Case Study – Risk, Validation and Critical Thinking
Digital Transformation and Superintelligence Platforms in Medical Devices
• Implementation Use Cases and Validation of Artificial and Superintelligence Platforms
• Speed Training and Networking – Discover Innovative Processes and Technology
• Risk, Bias and Cybersecurity in AI Platforms
• Using AI in 3d Printing
• Stay Up to Speed on Emerging Diagnostics – Software as a Medical Device
Use Cases in Compliance, Validation, Risk, QA – The Interrelationships between Design/Development and Manufacturing
Design/Development Track:
• A Case Study – Hollister’s Successful Transition from EU-MDD to EU-MDR with Focus on Technical Documentation
• Design Control – Validation and Verification of Inputs
• Implement a Risk Analysis and Management Program that Survives the Lifecycle
• Preparation and Survival of a EU MDR Audit
• Planning, Design History Files and Design Reviews
• Best Practices for a Medical Device Design Transfer
• 21 CFR Part 11 – How to Design and Comply
• Align Your Unscripted Testing Strategy with CSA
Manufacturing Track:
• Validation Strategies for Software Ecosystems
• Build a Medical Device Data Integrity Program from the Ground Up
• Conducting Impact Assessments for Change Control
• Shipping, Tracking and Packaging Validation
• Using and Validating Azure, DevOps, Smart Sheets
• MES – Implementation and Validation Case Study
• Qualifying Cloud Services as Part of Your Medical Device Quality System
• FMEA Templates and Managing Your Risk Ranking
Speakers:
🎤 Khaled Moussally: EVP Quality – Clients & Regulatory Relations, Compliance Group Inc.