Updated ISO9001 and ISO13485 Certificates Available for Fleet Bioprocessing Ltd.
Further to our successful audit by NQA last month, we have now received our new certificates for ISO9001: 2015 and ISO13485: 2016, which...
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Oct 23
Fleet Attending SEHTA MedTech Expo, London
Our MD Alastair Dent will be attending this year's SEHTA International MedTech Expo and Conference in London on Friday 1st November, feel...
Oct 15
Fleet's ISO9001 and ISO13485 Recertification Audit Successful
We're delighted to report that our three-day recertification audit by NQA went very well last week, with not a single non-conformance or...
Oct 3
Biomarker Assay Development and Validation: Ensuring Reliability in Clinical Applications
Biomarkers have become essential tools in modern medicine, providing critical insights into disease states, treatment efficacy, and...
Aug 12
FDA's QMSR and Synchronization with ISO 13485:2016: Insights from Document 89 FR 7496
In medical device regulation, the adherence to stringent quality management standards is pivotal. Regulatory bodies such as the U.S. Food...
Jul 19
Verification vs. Validation in Immunoassay and In Vitro Diagnostics
In the field of immunoassays and in vitro diagnostics (IVD), ensuring the accuracy and reliability of tests is paramount. These...
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