ISO 13485 FAQ with John Howlett

The medical regulatory landscape is undergoing its most significant overhaul in years, and with that comes a need to stay up-to-date with the latest regulatory intelligence and how the changes impact your organisation.

ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) was published on 1 March 2016, and we interviewed John Howlett, LRQA Medical Devices Technical Manager, for his views on the revised standard.