John Howlett, LRQA Technical Manager – Medical Devices
John Howlett joined LRQA as a Technical Manager - Medical in March 2015. He is responsible for all ISO 13485 accreditations and certifications, and he is involved in ISO 13485 training development and activities. Prior to joining LRQA, John held several positions at BSI including Head of Notified Body.
Widely recognised for his expertise within the medical device industry, John has participated in a wide range of European and UK medical device committees and has been actively involved in the review and implementation of the medical device directives and associated guidance documents. In 2012, John was also selected as an expert witness in the UK’s House of Commons Select Committee inquiry into the regulation of medical implants in the EU and UK.
John is qualified in Mechanical & Production Engineering, has extensive experience in Quality Assurance and has been actively involved as Lead Auditor against the requirements of ISO 13485 since its inception. Over this time, his experience has extended from auditing the largest of corporations through to the smallest of organisations and start-ups.
Flemming Nielsen, LRQA Technical Specialist – Medical Devices
Flemming Nielsen has worked at LRQA for 10 years. As a Technical Specialist for Medical Devices, he is responsible for unannounced audits under the MDD and QMS activities “MDD linked to ISO 13485”.
Flemming is currently involved in the assessor training for ISO 13485; prior to his current position, he has worked as an LRQA Lead Auditor within the MDD, IVDD, CMDCAS, ISO 13485 and ISO 9001 schemes.
Flemming has more than 14 years’ experience in the medical devices industry, and prior to joining LRQA has worked in quality departments of several medical device manufacturers.