Making the best use of the FDA Inspections Pause

Home / News, Views & Updates / Monthly Archives: September 2021

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

Blog Sign up

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