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

The ISO 13485 standard represents a Quality Management System base for many regulatory schemes.

With the recent publication of the new Medical Device and In Vitro Diagnostic Regulations, the regulatory framework surrounding Medical Devices evolves and re-enforces the control of external parties (Suppliers, Subcontractors).

The newest revision of the ISO 13485 standard published in March 2016 aims in the very same direction.

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The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing the EU’s current Medical Device Directive 93/42/EEC, the EU’s directive on Active Implantable Medical Device 90/385/EEC, and the In Vitro Diagnostic Directive 98/79/EEC.

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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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MDSAP Prepare the transition, worldwide market access

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ISO13485 Training

Transition to ISO 13485:2016
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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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