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We received our annual ISO audit from NQA recently and I'm very pleased to say that once again we had zero non-conformances - an excellent result confirming that we have maintained our world class quality standards for another year. You can find our current ISO9001 and ISO13485 certificates here: Quality & GMP As well as applying our unparalleled technical and industry knowledge to your project, you can rest assured that all of Fleet Bioprocessing's work is carried out to the

As of January 2025, the UK government has provided updated guidance on the regulatory requirements for in vitro diagnostic medical devices (IVDs) concerning UK Conformity Assessed (UKCA) marking. This guidance outlines the transitional arrangements and timelines for the acceptance of CE-marked IVDs on the Great Britain market, as well as the implementation of future regulations. Transitional Arrangements for CE-Marked IVDs To ensure a smooth transition and continuous supply o

Further to our successful audit by NQA last month, we have now received our new certificates for ISO9001: 2015 and ISO13485: 2016, which are valid until 30th November 2027. You can download copies of these certificates here: https://www.fleetbioprocessing.co.uk/quality-gmp

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 opportunity for improvement identified by the auditor. On the basis of this inspection, Fleet Bioprocessing Ltd. has been recommended for recertification to both ISO9001: 2015 and ISO13485: 2016 until November 2027 - which will take us to 27 years of uninterrupted compliance! For the first time ISO9001 compliance now requires companies like

In medical device regulation, the adherence to stringent quality management standards is pivotal. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the International Organization for Standardization (ISO) play crucial roles in shaping these standards. A significant framework introduced by the FDA is the Quality Management System Regulation (QMSR), with its alignment with international standards like ISO 13485:2016 emphasized in Document 89 FR 7496. Unp

As industries evolve, so do regulations governing them. The In Vitro Diagnostic Regulation (IVDR) was introduced to enhance the safety and efficacy of in vitro diagnostic medical devices (IVDs) within the European Union (EU). While its primary focus is on IVDs, the ripple effect of IVDR extends beyond its intended scope, creeping into regulated bioanalysis. This article explores the unforeseen consequences of scope creep from IVDR into regulated bioanalysis and how stakeholde

In the realm of modern medicine, diagnostic tests play a pivotal role in identifying and treating diseases. As technology advances, so too does our ability to develop increasingly sophisticated tests that can provide valuable insights into a patient's health. Among these are Laboratory Developed Tests (LDTs), which are designed, manufactured, and used within a single laboratory. On April 29th, 2024, the FDA made a significant announcement regarding the regulation of these tes

Introduction: In the realm of medical devices, particularly in vitro diagnostics (IVD), ensuring the highest standards of quality, safety, and efficacy is paramount. This is where ISO 13485, a globally recognised quality management standard for medical devices, plays a pivotal role. In this article, we will delve into the significance of ISO 13485 accreditation for in vitro diagnostic development and how it contributes to the overall success and reliability of these crucial h

Fleet Bioprocessing Ltd. are proud to report that we received zero non-conformances in our latest audit against the requirements of ISO9001: 2015 and ISO13485: 2016, which was carried out by NQA in December.

Fleet Bioprocessing Ltd. are proud to report that following an audit by NQA, we have been recertified to ISO9001: 2015 and ISO13485: 2016 until November 2024.

Fleet Bioprocessing Ltd. are proud to report that we received zero non-conformances in our latest audit against the requirements of ISO9001: 2015 and ISO13485: 2016, which was carried out by NQA in October.

Fleet Bioprocessing Ltd. are pleased to announce that our accreditation to ISO9001: 2015 and ISO13485: 2016 is now being handled by NQA, one of the world's leading certification bodies. You can find our new certificates here . Of course, there will be no change to our existing quality standards, which will always meet the highest industry and regulatory requirements...