FEATURED EDITORIAL
Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide
This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.
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India’s Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 that will shorten manufacturing license timelines while preserving quality, safety, and performance requirements.
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In June, Brazil's ANVISA released a batch of clinical trial petitions because its review deadline had expired without a decision. Take a closer look at what medical device companies should know.
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Let's take a closer look at the scientific principles, technological progress, and translational hurdles defining the present state of microneedle research.
INDUSTRY INSIGHTS
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Planning For Scale Up: Building For Long Term Flexibility
Decisions made during clinical manufacturing have lasting consequences at commercial scale. This article examines how fill/finish equipment choices shape long-term flexibility, throughput, and operational continuity.
Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.
Engineering decisions in fill/finish directly shape product quality and sterility assurance. This article examines how inert gas purging, plunger placement, dosing verification, and barrier systems interact across line design.
CCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, barrier configurations, component formats, and plunger placement affect integrity and line performance.
When packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.
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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