Industry 4.0 and Medical Devices
This white paper discusses the quality and regulatory approach for medical devices and software tools that contain AI/ML-based software.
Optimizing CAPAs in the Medical Device Industry
This white paper explores how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”.
Modernizing Medicare Coverage for Digital Health Technologies
This report focuses on ways to modernize Medicare’s payment and coverage policies.
Quality Function Deployment (QFD) for Design Controls
This white paper covers the history and evolution of quality systems and their application to medical devices.
Memo on Medical Technology Artificial Intelligence (AI) in China
Accelerating the advancement of AI could help China tackle some of its most difficult healthcare challenges.
Use Case: Application Of The Medtech Value Assessment Framework To Stereotactic Body Radiation Therapy For Non-Small Cell Lung Cancer (SBRT)
This use case examines SBRT as a viable alternative for the treatment of patients with non-small cell lung cancer.
Use Case: Application of the Medtech Value Assessment Framework to Cymedica’s e-vive™ System
This use case demonstrates the value of the CyMedica e-vive™ system technology across all of the identified value drivers and for a range of stakeholders.
Use Case: Application of the Comprehensive Assessment of the Value of Diagnostic Technologies Framework to Abbott’s 4th Generation ARCHITECT HIV Antigen/Antibody Combo Test
This use case demonstrates the value of Abbott’s 4th generation ARCHITECT HIV Antigen/Antibody combo (ARCHITECT HIV Ag/Ab Combo) test across all of the identified value drivers and for a range…