Webinars

The Pilot version of MDSAP started on January 2014 and was converted through a transitional period lasting until the launch (...)

In the context of EC type and EC Design examinations, LNE / G-MED provides Medical Device Manufacturers with a list (...)

Medical Device Manufacturers went through significant changes in the last couple of years: The publication of ISO 13485:2016 on February (...)

Each year, medical device incidents due to use/user errors caused mainly by poor user interface design are reported, some can (...)

In the current Medical Device Directives, Post Market Surveillance is defined in Chapter I, Article 2, (40a), as the action (...)

The biocompatibility is a preclinical aspect important for any medical device in contact with the human body. The subject is (...)

The publication of ISO 13485:2016 in March last year reinforced the notion of control of supply chain for Medical Device (...)

When developing E-healthcare technologies with the objective to market them in Europe, it is key to well understand the regulatory (...)

The origin of the proposed regulations dates back to 2008: The Medical Device Regulation and the In Vitro Diagnostics Regulation were initially proposed in (...)

Innovation triggers changes. The Medical Device Industry more than any other industry, follows the course of demands and needs that see thousands (...)

The certification audit is a major step for a Medical Device manufacturer to access the market. In this webinar, we will go (...)

In June 2016, the MEDDEV 2.7.1 rev 4, the European guidance on the clinical evaluation of medical devices (MD) was published. The issuance (...)

Software nowadays is a key component in healthcare industry. Medical device software, embedded in medical devices, can be found in (...)

The regulatory landscape for In Vitro Diagnostics (IVDs) in Europe is expected to go through some significant changes in the (...)

There is a growing need in the current global economy to outsource with no foreseeable turning back. Medical Device and (...)

With over one million certified companies over the world, the international quality management systems standards ISO 9001 and ISO 13485 (...)

The notified body that issued the design or type-examination CE marks regarding specific medical devices or products must approve any (...)

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

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 (...)

Have you ever wondered how the European Directives were made? What does “CE” stand for? Or Why do we call (...)

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

International market access is no small feat for a medical device manufacturer. Compiling the records that show how a device (...)

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

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

Recent regulatory evolutions in the EU have prompted manufacturers and notified bodies to take second looks at how medical device (...)