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Microbiological & Toxicological Quality and Safety of Medical DevicesSPEAKERS:Dr Jrg Degen Eurofins Lothar Fruth Toxicological Expert Services, Gttingen Jan Havel TV Sd Hana HofmanHther Eurofins Peter Huonker Zimmer Biomet Walter Zwisler Zwisler Laboratorium56 December 2017, Berlin, GermanyHIGHLIGHTS: Regulatory Requirements Sterilisation Methods Endotoxin Testing incl. alternate Methods Bioburden and Identification Biocompatibility Toxicological
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Microbiological refers to the study of microorganisms, which include bacteria, viruses, fungi, and protozoa, as well as their effects on humans, animals, plants, and the environment.
Individuals or organizations that handle, produce, or sell products that may be affected by microorganisms, such as food processors, pharmaceutical companies, and laboratories, are typically required to file microbiological reports.
To fill out a microbiological report, one should gather relevant testing data, include details about the samples tested, the methods used, results obtained, and any necessary compliance information, and then submit it to the appropriate regulatory body.
The purpose of microbiological testing and reporting is to ensure safety and quality in products, identify harmful microorganisms, and comply with health regulations to protect public health.
Information that must be reported includes sample identification, testing methods, results (including counts or presence/absence of microorganisms), date of testing, and the name of the laboratory performing the analysis.
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