ISO 13485:2016 Content Library

Our technical experts are hand-selected to provide input into the work of ISO 13485:2016 technical committees, and here they give you first-hand insights into the medical regulatory landscape.

Infographics

Interactive ISO 13485:2016 infographic for medical device manufacturers

Check out this interactive infographic to see how your medical device company can get certified to ISO 13485:2016 in 7 steps.

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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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Datasheets

CE Marking - What is the Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) is a new regulation governing the safety of medical devices available in the European Union (EU).

Work on the new MDR began in 2012 following the Poly Implant Prothèse (PIP) breast implants scandal.

The new Medical Device Regulation was published on 5 May 2017 by the Official Journal of the European Union. This new regulation – known as (EU) 2017/745 – replaces and repeals both the existing Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC.

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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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Guides

Medical Device Regulation - Are you prepared for the changes?

The European Union (EU) regulatory framework for medical devices consists of the Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC.

In the interest of simplification, both directives are combined under the MDR, which is introduced as a regulation instead of a directive, following a proposed revision by the European Commission on 26 September 2012.

A regulation was deemed the appropriate legal instrument as it imposes clear and detailed rules which do not give room for different interpretations by member states.

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How To Classify Your Medical Device - Classification Rules

To win in the highly regulated and high stakes world of medical devices manufacturing, it is crucial to beat the competition to the market, and minimise any potential losses from surprise product launch delays.

Our thorough yet streamlined approach ensures you get the right type of guidance at any stage of the product lifecycle, towards a timely market launch.

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