Why digitised design control is essential for the sustainability of your DHF

Posted on Posted in General, london_2018

Thanks to Laurence Sampson for writing this article, as a preview to the upcoming conference on Practical Solutions in CSV and SDLC for GXP & MedDev (London, 3/10/2018) In today’s competitive landscape, every stage of the regulatory process – from first submission through ongoing, annual or semi-annual iterations – is a make-it- or break-it-scenario. From delays to audit failures and […]

Why should quality assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)

Posted on Posted in Electronic QMS, General

It is all too easy to dive into the list of requirements contained within the ISO 13485 and achieve compliance by just ticking the boxes: looking at one requirement or one area at a time and making sure you have put in place something to address that requirement. This may easily result in a quality […]