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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; identify forms of treatment. R&D activities are subject to legal and regulatory frameworks and ...

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 work. As well as advancements in health and fertility treatments, a range of contemporary developmen...

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 cells are differentiated and designed to serve a certain function. Stem cells are undifferentiated,...

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 LIFE CYCLE-FOCUSED APPROACH MDD”) primarily focusses on the pre-approval stage of a medical device...

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) including, for instance, a mobile app that allows users to take pictures of moles on their skin and evalua...