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Medical Device Testing Articles & Analysis
8 articles found
Medical device biocompatibility testing is a quality control standard for the development and manufacturing of medical devices. ...
These medical device shelf life ISO standards provide guidance on how to determine a device’s expected shelf life — often referred to as the expected lifetime — as well as the testing protocols and procedures manufacturers should follow to ensure a device’s safety and effectiveness over a ...
Microbial Barrier Integrity: Bioburden tests determine if sterile packaging for medical devices resists microbial penetration. ...
The demand for research and MEDICAL DIAGNOSTIC products grows annually. Because medical diagnostic devices are used in the testing, treatment, prevention, monitoring, studying, and diagnosis of diseases and other biological human conditions, companies that develop and manufacture such diagnostic products are well positioned to ...
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 ...
The Indian Medical Devices industry is mostly import-dependent with no specific regulations in place till recent times. With the introduction of MDR (Medical Device Rules 2017) attempt has been made to harmonize the Indian medical device Industry as per globally prevailed ...
Abstract In the medical device industry it is becoming increasingly critical to ensure that parts are clean. ...
Customer: Butterworth Laboratories, United Kingdom Wilh nearly 40 years' experience, Butterworth Laboratories remains an independent UK con¬tract analytical service providing Method Development, Method Validation, Stability Testing and OC Testing to the pharmaceutical, medical device and chemical industries. ...
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