News, Views & Updates

Home / News, Views & Updates

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...

Read More

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...

Read More

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...

Read More

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) ...

Read More

ISO 45003 – Social Responsibility & Sustainability in Organisations

Our expert Tutor & training partner Gerry Higgins, talks us through the newly published standard ISO 45003:2021 which provides guidance on the management of psychosocial risks and promotes well-being at work, as part of an occupational health and safety (OH&S) management...

Read More

Blog Sign up

Sign up to receive the latest industry and company news direct to your inbox.