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.


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. 
Download full datasheet >


Interview series with Susan 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)  
Download the full interview >

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.  
Download the full interview >


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. 
Download full brochure >


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 
Download full FAQs >


Medical Device Regulation - Are you prepared for the changes?

According to the European Union, the MDR is expected to fulfil a dual aim – to ensure that medical devices are safe, whilst allowing patients to benefit from innovative healthcare solutions in a timely manner.

LR welcomes these as a positive step towards achieving the objective of the European Commission’s Joint Action Plan, delivering increased confidence in medical devices and the transparency and rigour of the assessment process itself.

More information is in this whitepaper ►

Knowledge Center

A range of valuable content and free resources about various topics like: ISO Standards Revisions, quality, environment, energy management, food safety, information security, medical devices, business continuity, risk management and others.