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Oxford Nanopore’s rapid LamPORE COVID-19 test to be made available via SourceBio accredited lab facilities Oxford Nanopore Technologies Limited (“Oxford Nanopore”), a leading next generation DNA/RNA sequencing technology company and SourceBio International plc (“SourceBio”), an international provider of integrated state of the art laboratory services and products, announce a strategic commercial partnership to offer a commercially…
Read MoreAs the regulatory bodies continue to evolve and increase their requirements, fashions change; and now the requirement from the FDA/MHRA/HPRA commands that all companies must have a Disaster Recovery/Business Continuity Management plan in place. Now is the time to start your efforts to meeting the ISO:22301 Business Continuity Management accreditation for your business. These are…
Read MoreWhat is a QMS? A Quality Management System is a collection of processes that primarily focus on consistently meeting customer requirements. An organisation has a QMS to ensure that its products or services satisfy the customer quality requirements and comply with any regulations applicable to those products or services. A QMS aims to: To enable…
Read MoreSource BioScience to use PrimeStore MTM kits for COVID-19 testing service EKF Diagnostics Holdings plc (AIM: EKF), the AIM quoted point-of-care business, announces that it has signed an agreement with Source BioScience UK Ltd (“Source BioScience”), which provides Laboratory testing services for the NHS, to supply PrimeStore MTM, a novel patented sample collection device, to…
Read MoreIn 2016 two new EU Regulations on Medical Devices were proposed, Regulation (EU) 2017/745, and in-vitro diagnostic Medical Devices, Regulation (EU) 2017/746. Since then, they have been going through the review and approval stages and were formally put into force in May 2017 with parts becoming legally binding in November 2017. There is a…
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