Latin America's Landscape For Medtech Clinical Trials
This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America,...
Source: clinicalleader.com
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The Role Of The Contract Manufacturer Under The EU MDR And IVDR
The Role Of The Contract Manufacturer Under The EU MDR & IVDR By Mark Durivage, Quality Systems Compliance LLC Regulation (EU) 2017/745 Medical Device (EU MDR) of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC Active Implantable Medical Devices Directive (EU AIMDD) and 93/42/EEC Medical Device Directive (EU MDD) was set for enforcement in May 2020. However, due to the global COVID-19 pandemic, the European Commission extended ...
Source: meddeviceonline.com
Prosidyan® Receives CE Mark for FIBERGRAFT® BG Family of Products
New Providence, NJ (PRWEB) May 20, 2021 -- Prosidyan, Inc. (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, receives two CE
Source: prweb.com
Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 6 Of 6) | MoFo Life Sciences
To embed, copy and paste the code into your website or blog: MDR”), which will govern medical devices software (“ MDSW”) in the EU, we turn to the transition periods certain MDSW can benefit from before being required to fully comply with the MDR. Transitional periods are provided in Article 120 MDR. In part due to the COVID-19 pandemic, the original text of Article 120 MDR has been corrected by two corrigenda (I, II) and another Regulation to avoid additional burdens to stakeholders and impasses in the supply of medical devices. The changes introduced by these amendments are twofold: O...
Source: jdsupra.com
Global Healthtech CEO Connect: Software As A Medical Device In The U.S. And EU Recap | MoFo Life Sciences
To embed, copy and paste the code into your website or blog: On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at...
Source: jdsupra.com