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Stepping into an MDSAP audit

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

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CE Marking of Medical Devices: Elements to be provided during the Evaluation of the Technical Documentation

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

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IVD European Regulation: how QMS requirements interacts with ISO 13485:2016

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

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Medical Device Usability: Highlights of European Regulations and the Latest Standards

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

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Post-Market Surveillance requirements under the new European Medical Device Regulations

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

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Biocompatibility: How to demonstrate the control of the biological risk according to the NF EN ISO 10993-1 (2010) standard?

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

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Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives

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

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E-health technologies in Medical Devices: identification of the key development milestones and regulatory constraints

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

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Medical Device & IVD regulations, impacts for MD manufacturers

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

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Notification of changes: How, what and when to communicate with your Notified Body

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

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Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers

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

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MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)

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 (...)

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Clinical and Performance evidence requirements in the future EU IVD Regulation

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

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Impact of Critical Suppliers and Subcontractors on Medical Device Market Approvals

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

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Evolution of ISO 13485:2016 and ISO 9001:2015 standards

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

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Embedded Software in Medical Device: Common Regulatory and Quality pitfalls

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

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Controlling Critical Subcontractors in 2014

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

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CE Marking Around the World: How to Enhance the Achievements of the CE Marking to Open More Markets

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

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CE Marking and the Roles of Notified Bodies

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

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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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CE Marking : Dealing with changes in medical devices in the framework of CE type and design examination

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

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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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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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Nanoparticles and Medical Devices : How to meet the regulation on the characterization of materials ?

This content is provided by LNE

This content is provided by LNE   Because of the high number of nanoparticles marketed in France in 2013 (more (...)

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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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MRI (Magnetic Resonance Imaging) safety and compatibility of medical devices

This content is provided by LNE

This content is provided by LNE   Over the last ten years, the number of MRI scanners in the world (...)

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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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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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