Our technical experts are hand-selected to provide input into the work of ISO technical committees, and here they give you first-hand insights into the medical regulatory landscape.

Datasheets

ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes)

ISO 13485 is the international standard that defines Quality Management Systems (QMS) requirements for organisations that design, develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices. Download the full datasheet to gain more insights. 
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Interviews

Interview series with Sarah Mecca - LRQA Technical Manager, Medical Devices about ISO 13485:2016


Interview 1 of 2: The New ISO 13485:2016
Overview of ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes)  
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Interview 2 of 2: Key Changes to ISO 13485:2016
Susan shares her thoughts on the new ISO 13485:2016 medical quality management system (QMS) standard, and how it impacts manufacturers.  
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Brochures

Keep a pulse on the latest in medical device regulations

With the medical regulatory landscape having undergone it’s most significant overhaul in years; comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation. 
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FAQs

The New In Vitro Diagnostic Device Regulation (IVDR)

Regulatory affairs professionals and device manufacturers are seeking clarification on how to implement the new IVDR requirements within their organisations 
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Knowledge Center

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