Menu
CRO Avania Acquires MAXIS Avania, a global medical technology contract research organization (CRO), has acquired MAXIS, a medical technology development service provider with expertise in pre-clinical engineering, design validation and verification, regulatory affairs, field clinical services, and trial management. MAXIS has offices in San Jose, California, and Frankfurt am Main, Germany, with additional operational staff across …
FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices The FDA is hosting a webinar on February 2 from 1:00-2:00pm ET for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices. The FDA announced that during this webinar it …
FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices Read More »
European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance On January 6, the European Commission adopted a proposal to give more time to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal now needs to be adopted by the European Parliament and the Council. The proposal introduces a …
European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance Read More »
The Real Impact of IVDR on Clinical Evidence Requirements For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work. With the shortage of notified bodies and resources, numerous outstanding guidance questions, as well as …
The Real Impact of IVDR on Clinical Evidence Requirements Read More »
Veranex Acquires Medidee Veranex, a global, tech-enabled service provider dedicated to the medical technology industry, has acquired MedTech consultancy Medidee, headquartered in Lausanne, Switzerland. The acquisition will expand and strengthen Veranex’s regulatory affairs, clinical development and quality assurance services for medtech companies, including an improved ability to navigate EU-MDR/IVDR challenges thanks to Medidee’s experience …
Medical Innovation Exchange @ Copywrite 2021. All Rights Reserved.