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Welcome to our Library of Regulatory, Certification Information and Updates in the Medical Device Area

Developing the right MRI safety assessment strategy

Medical devices manufacturers are regularly asked about the safety of their products when introduced into an MRI scanner (Magnetic Resonance Imaging).

These questions usually come from competent authorities, notified bodies or medical teams. This is the subject of a regulatory strengthening and forms part of a growing number of standards (ISO 14630, ISO 14708, EN 45502, etc.).

The placing on the market of an implantable device is now impossible in some countries without prior information on the product safety during an MRI exam.

Therefore it becomes a major issue for MD manufacturers, especially with regard to implantable Medical Devices.

  

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Clinical Evaluation Medical Devices MEDDEV

In June 2016, the new version (Rev.4) of MEDDEV 2.7.1 European guidance on the clinical evaluation of medical devices (MD) was published. It does not revolutionize the clinical evaluation approach but significantly increases the demands on the content of the file.

The new guidance is longer and more detailed, in order to provide numerous supporting examples and to clarify some terms. It does not introduce new requirements per say.

This newsletter presents the changes introduced by the guidance revision, applicable since June as there is no transitional period planned in the text.

 

 

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Oct 20 New EU Regulation OCRA

Orange County Regulatory Affairs Discussion Group (OCRA) is inviting QA/RA management as well as key decision makers (CEO, CFO, and Internal Counsel) to discuss the business and financial implications of meeting the new regulations and engage with both seasoned Industry and Notified Body professionals to obtain valuable insights and information on how to proactively prepare for the transition to the new EU regulations for medical devices and IVDs.5.

This year, Jawad Mahdavi, Lead Auditor at LNE/G-MED North America will discuss the new MD regulation and its Implications for Medical Device manufacturers.

To download the program and register, click here.

 

Webinar Embedded Software in Medical Device

Join us on Wednesday, September 28th at 2:00 PM Eastern Time as LNE/G-MED North America Inc. will be hosting a free informative session on Embedded Software in Medical Device : Common Regulatory and Quality pitfalls.

Register Now!

 

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requirements of in vitro diagnostic devices

In September 26th 2012, the European Commission proposed a draft for an in vitro diagnostic Regulation in order to overcome flaws and divergences in interpretation of the current IVD Directive 98/79/EC and to further strengthen patient safety.

Since then this draft have been amended by the European Parliament in October 2013 and the European Council provided its approved revision on September 21st 2015.

 

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ISO 9001

Since its first publication in 1987, ISO 9001 has been revised several times to remain relevant and in line with the market needs of businesses. A new revision of the standard was launched in September 2015; replacing the latest version published in 2008. With over 1.2 million companies certified around the world, ISO 9001:2015 introduced several changes; some of those are significant as they impact key areas of the companies’ Quality Management System.

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Free webinar medical device

Join us on Wednesday, June 29th, 2016, at 2 pm Eastern Time as LNE/G-MED North America Inc. will be hosting a free informative session on Clinical Evaluation Requirements for In Vitro Diagnostic Devices (IVDs) in the upcoming IVD Regulation.

Register now!

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New Medical Device RegulationThe Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement on the drafted Medical Device and IVD Regulations.

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Impact of Critical Suppliers and Subcontractors on Medical Device Market ApprovalsThere is a growing need in the current global economy to outsource with no foreseeable turning back. Medical Device and In Vitro Diagnostic Manufacturers in the United States are in constant need to tap in new markets (Europe with CE marking, Canada with CMDCAS and soon Japan, Brazil and Australia with MDSAP), increase ability to respond to opportunities/demand and concentrate their efforts on innovation. Without the concept of outsourcing supply chain links, the medical device market would be in slow motion and startups will struggle to exist.

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ISO 13485 2016 standard medical device

On March 1st, 2016, the latest revision of ISO 13485, the internationally recognized Quality Management Systems standard for the medical device industry was officially published. ISO 13485:2016 is now here and ready to take over ISO 13485: 2003.

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