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Medical Devices For Safety Articles & Analysis

3 articles found

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

Guidance for Industry and Food and Drug Administration Staff Introduction This guidance document provides Food and Drug Administration’s (FDA’s or the Agency’s) recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic ...

ByKOPP Development Inc.


A Quick Overview of ISO 13485 Requirements for Medical Device Companies

A Quick Overview of ISO 13485 Requirements for Medical Device Companies

It is an undeniable fact that safety and quality are the top-most priority for medical device companies. ...

ByQualityze Inc


How to Properly Clean Medical Devices

How to Properly Clean Medical Devices

When it comes to medical devices cleanliness is crucial. All medical devices, whether they are disposable, implantable or reusable, must be cleaned during the manufacturing process to remove oil, grease, fingerprints and other manufacturing soils. ...

ByInternational Products Corporation

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