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Medical Device Compliance during Merger and Acquisition and the role of Notified Bodies

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

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Upcoming revisions of EU regulations & the reclassification of In Vitro Diagnostics

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

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Upcoming revisions of EU regulations & the reclassification of In Vitro Diagnostics

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

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Reclassification of Medical Devices, upcoming revisions of EU regulations

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

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Recent EU Medical Device Regulatory Evolutions: Moving Forward

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

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Medical Devices Containing Ancillary Medicinal Substances

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

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The IVD Directive and borderline products

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

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Russia Medical Device Market Access, ISO 13485, and CE Marking for Medical Device Manufacturers

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

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Medical devices intended for home use: what are the requirements of EN 60601-1-11 ?

This content is provided by LNE

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

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Sampling Medical Devices for Testing during Unannounced Audits

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

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INMETRO and its Role in the Brazilian Medical Device Registration Process

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

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How to change notified bodies (NB) for LNE/GMED ?

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

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Mexico Medical Device Market Access and ISO 13485 certification

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

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Stand-alone software classification & regulation in Europe

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

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Transfer notified body

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

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The Clinical Evaluation Demonstration of clinical safety and performance

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

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IVD Technical File Compilation

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

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Evolutions in the EU IVD Regulatory Framework

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

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Understanding ISO 14971 2012

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

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Future of the IVD Directive: Expected Regulatory Change Based on European Commission

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

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