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This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America,...

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 enfo...

New Providence, NJ (PRWEB) May 20, 2021 -- Prosidyan, Inc. (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, receives two CE

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 ...

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 ...

Introduction The research and development (R&D) of medicinal products is important both from an individual perspective, considering its objective to identify and treat pathologies (with the consequent improvement in patients quality of life), and from a collective perspective, considering its role in controlling the spread of diseases or eradicating them altogether. R&D activities can be defined as activities carried out in humans (who may be healthy or ill) to: improve knowledge of pathologies...

Fertility Treatment: Are Cryogenics the Key? Image Credit: Air Products PLC Developments and research are ongoing, but there have already been considerable advancements in reproductive medicine over recent years. More options are available than ever before in terms of the management and potential treatment of infertility, while new and innovative alternatives are increasingly available for people unable to conceive or at risk of becoming sterile. Cryogenics offers a potential advantage to this ...

Stem Cells: How Long can They be Stored? Image Credit: Air Products PLC The science of regenerative medicine and stem cell applications is continually advancing. These techniques are employed in the treatment of illnesses and immune disorders, ultimately saving lives. Blood and cell samples can be stored using cryogenics, but it is important to be aware of the applications of these materials and how long they can they survive in cold storage. Stem cell applications The majority of the body’s...

To embed, copy and paste the code into your website or blog: After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our series on Software as a Medical Device in Europe, we will now explore key changes to the quality assurance and documentation requirements for stand-alone medical device software (“ MDR”). INTRODUCTION: A NEW ...

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“ MDSW”) under the new EU Medical Device Regulation 2017/745 (“ MDR”) in part 2 of our series of articles, in this part 3, we now turn to the issue of risk classification of such MDSW under the MDR. INTRODUCTION MDD”), most stand-alone MDSW ( i.e., MDSW not implemented in a more complex medical device, such as control software) includ...