The European Centre for Connected Health seeks to attract medical technology companies to Belfast. This article also discusses other companies located in the Northern Ireland Science Park, a high-tech business incubator in Belfast's Titanic Quarter. Click the link to the right for the full text ...
in the European Commission's EU medical device database EUDAMED under a unique Single Registration Number (SRN): XI-AR-000001836 for the markets of EEA/EU27 & Northern Ireland.Wellkang is also a registered UK Responsible Person (UKRP) in the UK MHRA medical device database for the market ...
Medical Design & Outsourcing covers technical advances fueling innovation in medical device design, development and manufacturing.
According to the U.S. Government Accountability Office, sales for 102 medical device companies in the United States increased 43% between 2005 and 2014.(2)Those numbers may give medical device manufacturers a reason to cheer. A good profit margin always boosts the morale of CEOs. However, if ...
2023 – medical companies operating on the British market will be obliged to receive UKCA certification instead of CE marking, with medical products sold in Northern Ireland still requiring the latter. Healthcare products that require to be assessed by a Notified Body will need to be check by an...
Previous obligations around storage, transportation and checking device labels for CE or UKCA mark will continue to apply. The importer's name and address will not need to be present on the label unless the importer or distributor are acting as the UKRP for the purposes of the UKC...
This is more tricky, and a business model of many companies. Companies sell direct to the Union customer and deliver the device via a fullfilment service provider in the Union. This is not a clearcut scenario under the MDR or IVDR, but it is clear cut under the Market Surveillance ...
2.A procedure performed on a person for diagnosing or treating a disease. McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc. Want to thank TFD for its existence?Tell a friend about us, add a link to this page, or visitthe webmaster's page fo...
The MHRA (The Medicines and Healthcare products Regulatory Agency), who is the UK national regulator for these products, has outlined a transition period for the registration of these products (from 4 to 12 months depending on the device). The MHRA confirmed that medical devic...
3D models for surgical planning and device manufacturing. Axial3D primarily caters to hospitals and medical device companies, providing tools to improve patient outcomes and accelerate the development of patient-specific medical devices. It was founded in 2014 and is based in Belfast, Northern Ireland...