QMSR: How medical device manufacturers can move beyond checklist compliance and build inspection-ready quality systems For years, many medical device manufacturers approached FDA inspections through a familiar lens: prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against...

Cercare Medical, a leader in advanced neuroimaging software, announced FDA 510(k) clearance (K253831) for its Cone-Beam CT (CBCT) Perfusion solution, enabling qualitative perfusion assessment directly from cone-beam CT data acquired during neurointerventional procedures.  The clearance marks an important step forward...

Quvara Medical, a newly formed medical device manufacturing business has secured a seven-figure funding package from HSBC UK to acquire a major medical technology production facility in Swindon.   Quvara Medical, part of the Buckland Group, which specialises in the production of autoinjectors, pen injectors and precision components for pharmaceutical and biotech partners, has used the...

Northern Ireland–headquartered medical device manufacturer’s climate targets are now SBTi-validated, placing the business in the top 1% globally for climate action. This World Earth Day, Eakin Healthcare has announced that its climate action targets have been officially validated by the...

Ceryx has strengthened its Board of Directors with the appointment of Mark Strong, a highly respected medical devices executive with decades of global leadership experience. Mark has held numerous senior executive roles in heart failure therapy development including Vice President...

Medical devices are becoming smaller, lighter and more portable. From handheld diagnostic tools to wearable infusion pumps and compact surgical instruments, reduced size is now a defining feature of many new Medtech products. While miniaturisation brings clear benefits for patients...

Whether it’s the whisper-quiet precision needed in medical devices or the durability required in aerospace applications, engineers face the challenge of finding drive solutions that meet exacting performance demands. The answer often lies not in compromise, but in fully customised...

Siemens Healthineers has officially opened a new Centre of Excellence for Immunoassay Instrument Research & Development in Swords, Ireland, with the opening carried out by Darragh O’Brien, Minister for Transport, Climate, Environment and Energy for Ireland, together with Michael Lohan, CEO of...