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In the last couple of years, the medical device industry has seen record numbers of mergers and acquisitions. When a (...)

Last May, the European (EU) Council published its position on the draft regulations for Medical Devices and IVD. Despite not (...)

Last May, the European (EU) Council published its position on the draft regulations for Medical Devices and IVD. Despite not (...)

Last May, the European (EU) Council published its position on the draft regulations for Medical Devices and IVD. Despite not (...)

In June 2015, the EU Council published a set of revisions to the EU medical devices and IVD regulatory proposals, (...)

Developing and marketing a medical device combined with a medicinal substance requires an acute understanding from the manufacturer of its (...)

For manufacturers, knowing whether their product is a “medical device” or “an in vitro diagnostic medical device” is crucial but (...)

The Russian medical device market is one of the largest for exporters. With over 140,000,000 people, Russia is a lucrative (...)

This content is provided by LNE   Electrical security requirements for medical electrical devices and systems for home healthcare environments (...)

Systematic unannounced audit are now broadly implemented following the European Directives requirements and Recommendation 2013/473/EU. One of the provisions of (...)

Brazil’s medical device market expanded at double-digit rates through 2011-2013, and is expected to continue this rate as 2014 turns (...)

In a continuously changing regulatory framework where the future of some notified bodies is uncertain, more and more companies require (...)

Medical device manufacturers both in Mexico and around the world can leverage some of their expertise with their quality systems (...)

Software (embedded, standalone, Apps) has become more important in the medical field. Medical software is nowadays essential because of its (...)

Transferring notified bodies is a critical process and a manufacturer should make this decision carefully. The reasons that medical device (...)

Clinical Evaluation is key for the demonstration of the clinical safety and performance of the devices. Why is it so (...)

A technical file is key for a medical devices’ CE marking conformity assessment. The technical documentation, also called technical file (...)

The EU in vitro diagnostic medical device regulatory landscape is changing drastically. The changes of the IVD Medical Device Directive (...)

Risk management is a key portion of the medical device lifecycle, from design to discard. It applies to all class (...)

One of our Project Managers Lead Auditors in IVDs, Darren Walsh, has attended the AdvaMed 2011 conference on Tuesday, September (...)