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Why is everyone talking about MDSAP and Health Canada? Read blog 2 / 3

As we have seen in the first of our blogs submitted by John Lafferty, MDSAP is the Medical Device Single Audit Programme which consists of a single Quality Management System (QMS) audit for the following five countries; Australia, Brazil, Canada, Japan and the USA. The programme...

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Why is everyone talking about MDSAP and Health Canada?

This blog is the first of a three-part blog about MDSAP, the Medical Device Single Audit Programme which will be mandatory by Jan 1st 2019 for all medical device manufacturers selling to Canada. In this blog we will answer the following questions: – Will CMDCAS be available...

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EU medical device in vitro diagnostic medical device regulations November 2017

The EU’s Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) came into force on 25 May 2017 and will replace the EU’s current Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC). Manufacturers of currently-approved ...

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ISO 13485:2016 – Guidance for your organisation to transition

We have just launched a new ‘ISO 13485:2016 – Update’ training course. ISO EN 13485:2016 was published on 26th February 2016 and companies have a three year transition period in which to comply. This ½ day course has been designed by our expert tutor, Kevina O’Donoghue, ...

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Cleanroom Standard ISO 14644-2:2015 Key Updates

The prime function of ISO 14644-2 is to prove continued compliance with ISO 14644-1. The 2015 edition emphasises the need to consider a monitoring strategy in addition to the annual cleanroom revalidation or initial validation in order to gain a continuing flow of data over time ...

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