Newsletter | March 5, 2024

03.05.24 -- Understanding Australia's Regulatory Framework For SaMD

FEATURED EDITORIAL

Understanding Australia’s Regulatory Framework For SaMD

In 2021, Australia's Therapeutic Goods Administration implemented reforms covering a wide range of software, including software as a medical device (SaMD), with the goals of clarifying the scope of regulated software products, introducing new classification rules, and updating the principles governing software-based medical devices.

INDUSTRY INSIGHTS

The Importance Of Material Selection In Micromolding Applications

Learn how the critical properties of micromolded components — such as strength, flexibility, and thermal resistance — are shaped by the intricacies of material selection.

Measuring Cleanliness

Learn about methods of detecting and measuring cleanliness in relation to soil quantities.

Effective Communication Drives Successful Manufacturing Transfers And Productive CMO Relationships

While lift-and-shift scenarios — wherein manufacturing is moved from one site to another without product or manufacturing process redesign — are ideal, they also are a rarity.

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Use-Related Risk Analysis For Combination Products

5 Focus Areas For Medtech Business Success In 2024

Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices And Biopharma

EEG Technologies Grow Beyond Traditional Diagnostics

Human Factors Engineering Concepts For The Design Of Combination Products

RESOURCES

Two-Shot Molding: Improving The Manufacturing Process

Advanced Tubing Retainers: Pharma+

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