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Medical Devices: Conformity Assessment and the UKCA Mark
This article provides an overview of the recent MHRA update for UKCA conformity assessment for medical devices, with practical insights for regulatory, quality, and executive teams.
Are Audit clip boards and checklists obsolete?
Are your quality and audit team ready for the digital shift? Do they have the right mindset? The tools are there is it time to assess which ones are right for your organisation.
Major Changes to MHRA Medical Device Registration Fees
There is a hard stop to the change process, from 1st April the system will be operable, and the products registered at that point will decide the fees payable for 2026/27. So, there are a number of actions manufacturers and UKRPs will need to consider.