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.

Case Studies

Oceanz’s ‘Selective Laser Sintering’ printing

Oceanz is the first prosthetic vital human organs 3D printing company in the Netherlands to receive certification against the medical devices quality management system ISO 13485, and the quality management system ISO 9001.

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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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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 service providers, including manufacturers of materials or component parts that are used in medical devices.

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Interviews with LRQA Medical Devices Technical Managers

Overview of the new ISO 13485:2016 with Sarah Mecca
Read about the new ISO 13485:2016 medical devices quality management system, its impact on your business, and how your organisation can benefit from the new standard. 

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FAQs Interview with John Howlett
Howlett shares his views on the revised ISO 13485 and answers frequently asked questions.

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ISO 13485:2016 Overview

ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. Transition to the new standard must be completed by March 2019, and with that in mind medical device manufacturers are seeking clarification on how to implement the new requirements before the deadline.

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Own Brand Labelling of Medical Devices: Clarifying Current Expectations for CE Certification

Before undertaking the Own Brand Labelling (OBL) route to market, it is worthwhile examining the historical and current regulatory expectations for CE marking certification of medical devices, and identifying the key legal obligations required of OBL manufacturers.

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