Newsletter | April 15, 2021

04.15.21 -- Implementing EU MDR and IVDR: Lessons Learned, Part 2

 
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The Criticality Of Process Validation

Process validation is critical in medical device manufacturing, but it often doesn’t get the attention it requires. This article offers guidance for creating validation processes and helps identify the personnel who should create and maintain them.

Dye Ingress For CCIT: A Poor Bet In A High Stakes Game

The dye ingress test method continues to be a widely used test method for container closure integrity. This paper explains why the dye ingress test method is not a suitable approach.

Why On-Demand Manufacturing Works Like Amazon Prime For Medtech Companies
The world’s growing on-demand economy and the idea of real-time fulfillment of goods and services now drive business, whether it’s a business-to-consumer transaction at Amazon Prime or a business-to-business exchange at companies like Protolabs.
Optimizing Sample Handling In Macromolecular Crystallography

Creating a high-resolution picture and subsequent 3D atomic model of a biological macromolecule is a complex process. Embeddable RFID tags from HID Global were chosen for sample identification, due to their tiny footprint and proven track record to work in cryogenic environments and the ability of HID for custom tag designs to meet high demands.

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