Medical Device Directive Articles & Analysis: Older
11 articles found
Medical device biocompatibility testing is a quality control standard for the development and manufacturing of medical devices. ...
The Medical Device Directive 93/42/EEC (MDD) is a regulation that sets out the essential requirements that medical devices must meet before they can be placed on the market. In this article, we will explore the importance of the MDD, the rigorous steps taken to achieve it, and what it means for your ...
Food & Drug Administration (FDA) quotes the International Medical Device Regulatory Forum’s definition: "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." ...
Nanostics’ biomarker and machine learning-powered test, ClarityDX Prostate®, received a CE-IVD Mark. A CE-IVD Mark is required for all in vitro diagnostic (IVD) devices to be placed in the European Economic Area, Iceland, Norway, and Liechtenstein and allows Nanostics to market and sell ClarityDX Prostate® in these countries. The ClarityDX Prostate® test provides patients ...
Medical Tech innovators, Neteera Technology developed their flagship device ‘Neteera 130’ to provide enhanced remote monitoring of patient vital signs, to improve care, and ultimately reduce healthcare costs while enabling optimal comfort for the patients. The Neteera 130 system (marketed as a ‘digital nursing assistant’) provides a continuous, contactless, passive vital ...
As technology continues to advance software has become an important part of most products. It has become integrated widely into medical platforms. In 2019, the Software as a Medical Device (SaMD) market was estimated at about $18.4 million, and it is projected to reach $86 million by 2027 at an annual growth rate of 21.9%. As one of the fastest growing sectors in healthcare, we explore when ...
The global COVID-19 pandemic has spurred on a new demand for diagnostic equipment and products in the race to minimise spread. Airports, workplaces, border checkpoints, hospitals and countless other facilities - they’ve all needed accurate qPCR testing capabilities. ...
In the Focus: Inmatec Gasetechnologie Gmbh & Co.Kg Medical oxygen plays an important role in coping with the corona crisis. It is used worldwide to treat Covid patients and is now also used to manufacture life-saving vaccines. With self-sufficient O2 generation, hospitals and pharmaceutical manufacturers secure the supply and reduce their costs at the same time. Medical oxygen has been used ...
It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet ...
The Indian Medical Devices industry is mostly import-dependent with no specific regulations in place till recent times. With the introduction of MDR (Medical Device Rules 2017) attempt has been made to harmonize the Indian medical device Industry as per globally prevailed ...
Medical device manufacturers are constantly looking to improve their device designs to increase their performance levels. There are a number of different trends in the medical device industry that manufacturers will have to consider when bringing a product to market. One of the most common trends in the medical device industry is to connect metals and plastic. Another is to enable “real ...