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

What began in 2012 at the initiative of the European Commission came to an end during the plenary session of April 5th, 2017, with the adoption by the European Parliament of the new regulations on Medical and In Vitro Diagnostic Medical Devices (MDR and IVDR)

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Training ISO 13485 2016With over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used.

Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016.

Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

 

 

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Certification AuditThe certification audit is a though exercise and a major step for Medical Device Manufacturers looking to access a targeted market. 

If you are looking to launch your company and your products or simply step into the world of the medical device industry, then be sure to thoughtfully plan and prepare your initial certification audit.

LNE/G-MED in this edition of the February newsletter, is discussing the most common pitfalls observed during a company’s first audit, pitfalls which may delay or simply prevent the company’s access to market.

Based on our experience with ISO 13485 and CE marking audits, most of these topics lead to major non-conformities ( NCs ) which need to be fixed prior to obtaining Certificates and that could therefore impact the certification timeframe. 

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Medical Device Regulation CEWelcome to 2017. With the new year rolling in, here come new resolutions … or should we say new Regulations.

In June 2016, political agreements on the medical device and in vitro diagnostics medical device regulations were released and we are expecting these two new European regulations to be voted and published during the year 2017.

These two regulations are bringing numerous changes, so it is crucial for manufacturers, who will be impacted by these changes, to be ready.

For this first newsletter of the year, we will present 5 major changes for each regulation, based on the published political agreements.

 

 

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Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Certification Project Manager - In Vitro Diagnostics responsible for medical device manufacturing clients.