Newsletter | May 4, 2021

05.04.21 -- Overcoming Funding Challenges For Innovative Medtech In Germany: Learnings From The NUB Process

 
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Demystifying Performance Testing: Strategies To Qualify Combination Products

Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidance. Following this, performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed, considering highest risk failure modes first.

Package Inspection Guidelines For Sterile Medical Products

Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection methods. A variety of inspection methods exist for medical package inspection that require a thorough understanding to ensure quality.

Medical Imaging Quality Starts By Selecting The Right Components

MRI machines use a strong magnetic field and computer-generated radio waves to produce cross-sectional images. Thus, the quality of the MRI depends on the uniformity of the magnetic field and the radio components inside it.

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