Newsletter | September 7, 2023

09.07.23 -- Agile Software Development, Part 3

FEATURED EDITORIAL

Agile Software Development In Biopharma And Medical Devices, Part 3

Computer software and systems validation testing are used to validate software under GxP environments. Parts 1 and 2 of this article series shared agile methodology with regard to the phases of planning, team structure and collaboration, software architecture, and more. In this final installment, the author discusses software release, configuration, change management, CAPA, and more.

INDUSTRY INSIGHTS

Modeling Tissue Responses In Drug Injection

Optimizing delivery along with the formulation is the key for successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force, and needle length.

Membranes Allow For Greater Functionality In Oxygen-Dependent Sensors

Wearable biosensors have been widely adopted for diabetes management and hold potential for broader applications. Explore polymer formulation's role in expanding this technology's reach.

The Dynamic Regulatory Environment Of Drug-Device Combination Products

Examine the dynamic regulatory environment of drug-device combination products, as well as concrete steps to take to navigate regulatory complexities and decrease time-to-market.

Why Perform A Product D-Value Study?

Follow our discussion on non-heat-sensitive aqueous liquid products sterilized and the use of the overkill method and bioburden/BI method.

Micro-Medical Manufacturing Tolerances

Accurate miniature plastic parts are achieved through precise tooling processes such as micro-tooling and injection molding, ensuring repeatability and accuracy for advanced micro-medical devices.

ARTICLES YOU MAY HAVE MISSED

5 Key Factors To Gain Regulatory Approvals For Innovative Rapid Diagnostic Devices

Phototherapy Devices: Where Is The Field Headed?

Materials Innovation: Propelling A New Era For Medical Devices

The Importance Of Software Validations For Medical Devices

Cleaning Process Development: Determining Critical Process Parameters

BULLETIN BOARD

Medical Balloons And Balloon Catheters

Partner with Nordson for a complete solution to your catheter-based device needs. Our Catheter Center of Excellence, located in Galway, Ireland, offers a full range of in-house capabilities.

RESOURCES

Assembly And Packaging Brochure

Control Solenoid Valves Brochure

Avoid False Positive Results In Endotoxin Testing

Micro-Molding Services

Connect With Med Device Online: