Company Training Courses

Harmonisation of Z Annexes for ISO 14971:2019 in Q1 2022

The Z Annexes for ISO 14971:2019 have been published and will be Harmonised in Q1 2022. It has been a long two years since ISO 14971:2019 Medical Devices – Application of Risk Management was published but the European Amendment containing the Z Annexes has finally been publishe...

Making the best use of the FDA Inspections Pause

Our Life Sciences industry expert Tutor, Gerry Burke, makes some suggestions as to how Medical Device, Pharma and Biopharma manufacturers can make the best use the ongoing pause in FDA Inspections. The FDA has stated that it has ‘no plans to resume foreign inspections for opera...

Understanding the Software Validation Requirements of ISO 13485:2016

With the transition of many medical device companies to ISO 13485:2016 “Medical Devices – Quality Management Systems – Requirements for regulatory purposes”, it is a challenge for the industry to obtain suitably qualified software validation engineers to fulfil its requir...

IVD Manufacturers counting down to compliance and the new EU Regulations

IVD Manufacturers: Will you be Compliant with the new EU Regulation 2017/746 when it comes into effect on IVDR by May 2022? Updated insights from our expert Tutor in Medical Devices John Lafferty As we all know, EU Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) comes i...

Overview of a Process Flow for a Management System

This diagram taken from our new IRCA accredited Introduction to Process Design training with expert Tutor Liam Regan shows an overview of a management system from a process flow perspective – notice the direction of flow indicates a cyclical process (in line with the PDCA) ...

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