The Benefits of Conducting a Gap Analysis for Your Business
Gap analysis is a process that compares an organisation’s current state to its desired future state in order to identify any gaps or disparities that need to be addressed through remediation activities. It is a process of reviewing and evaluating an organisation’s medical device documentation in order to identify gaps or deficiencies when compared to […]
UK Responsible Person: What Are the Requirements?
Since the UK’s exit from the EU in January 2021, several changes have been implemented, which are required by manufacturers to market their medical device(s), including IVDs, custom-made devices and system or procedure packs on the UK market. One of those changes has been the requirement for non-UK manufacturers to appoint a UK Responsible Person […]