FEATURED EDITORIAL
Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices
Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.
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![Open door with question mark-GettyImages-1344958335]( "What To Expect When You Move Into Production For The First Time")
In medical device development, things don’t go quite as you planned the first time around. This article shares what to really expect when you take your device into manufacturing.
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![Globe and Keyboard showing America-GettyImages-183795467]( "Key Regulatory Landscapes For SaMD Around The World")
As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are evolving to keep pace.
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![Artificial Intelligence American Superhero Robot, american flag-GettyImages-2149027472]( "A Look At Elsa, The FDA's New AI Digital Assistant")
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.
INDUSTRY INSIGHTS
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![Brazil-GettyImages-157287554]( "Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials")
Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical TrialsBrazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape.
A medical device manufacturer raced to launch a new product in a greenfield facility to overcome tight timelines and compliance challenges by replacing paper SOPs with a dynamic digital solution.
A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.
Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.
A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.
SOLUTIONS
MagnaAmp® is a self-contained biological indicator ampoule for monitoring steam sterilization of liquids in ampoules, large containers, or washer sterilizers.
Components with a copper barrier and a tin finish on top provide a fully non-magnetic component to be used in medical applications where non-magnetic components are required.
Comprehensive analytical and device testing services are available for injectable drugs, ensuring optimal primary packaging, compliance, and reliability throughout the product development lifecycle.
The Melles Griot XPLAN Lens Series fluorescence microscope imaging systems enable the rapid development of breadboard instruments for next-gen sequencing, proteomics, and spatial biology applications.
Canon's brushless servomotors are compact in size and provide high output power. Two types are offered with quick response and smooth rotation. Various custom options can be incorporated to fit your applications.
Nordson MEDICAL is a pioneer and innovator in the design, development, and manufacturing of medical tubing, with decades of experience. We have the broadest, most versatile medical tubing line in the industry. From simple medical tubing to complex, tight-tolerance extruded tubing in a wide range of materials including polyimide tubing, we can meet your needs.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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