Keyword: Safety regulations and standards

Stories

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Features: Manufacturing & Prototyping

Radiation medicine pioneer Elekta is growing fast. In anticipation of regulatory changes requiring more documentation and labeling, the company implemented a...

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Features: Medical
Although the pandemic has delayed the MDR’s validation date, it has not diminished the importance of this new regulation.
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Technology Leaders: Medical
Modern evaluation of biocompatibility uses a risk-based approach.
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Technology Leaders: Electronics & Computers
With longer lifespans and aging populations worldwide, the need for and importance of dialysis technology will only grow.
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Briefs: Regulations/Standards
Deadlines are approaching for compliance.
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Briefs: Medical
This relationship is important to understand when developing the end system.
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Technology Leaders: Electronics & Computers
Ventilators are mission-critical to sustaining life and require a robust design to ensure they maintain the necessary up-time for patient care.
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Briefs: Manufacturing & Prototyping
Removing organic contaminants and reducing bacterial and viral loads in medical device manufacturing.
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Briefs: Medical

“Seventy-five percent of all fatal motorcycle accidents globally involve brain injury, with rotational forces acting on the brain being the primary cause of death,” According to NHTSA....

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Briefs: Regulations/Standards

Medical device companies recognize that having an emphasis on design controls helps to assure good design and engineering practices that yield high-quality solutions. This is critical...

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Features: Regulations/Standards

FDA’s introduction to its rules for medical device regulation states: “Medical devices are classified into Class I, II, and III. Regulatory control...

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Ask the Expert

Dan Sanchez on How to Improve Extruded Components
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Improving extruded components requires careful attention to a number of factors, including dimensional tolerance, material selection, and processing. Trelleborg’s Dan Sanchez provides detailed insights into each of these considerations to help you advance your device innovations while reducing costs and speeding time to market.

Inside Story

Inside Story: Ensuring Reusable Devices Are Safe for the Next Patient
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To find out more about the expertise required to establish safe processes for cleaning and disinfecting reusable medical devices, MDB recently spoke with Elizabeth Sydnor, Director of Microbiology Medical Device Testing, Eurofins Medical Device Testing (Lancaster, PA).

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