Henry Sibun BSc (Tech) Hons, MSB CBiol, MCQI CQP

Henry Sibun BSc (Tech) Hons, MSB CBiol, MCQI CQP has over 24 years' experience in the medical device industry having worked on three sides of the camp – (1) as a Quality Manager implementing the Medical Devices Directive (MDD), ISO 9001 and EN 46001/ISO 13485, (2) as a Senior Manager, Lead Notified Body Auditor & Technical Expert for the largest Notified Body – TUV SUD Product Service, and (3) as a Consultant & Trainer.

Henry is an IRCA registered Lead Auditor and Chartered Member of both the Royal Society of Biology and the Chartered Quality Institute. After graduating with a 2.1 degree in Applied Biology from the UWIST in Cardiff Henry worked for the Water Board in Sydney completing a large project on microbiological beach pollution as a result of storm-water run-off. On returning to the UK he managed a small QC microbiology laboratory for a food company before moving on to a medical device manufacturer in 1993.

As the Quality Control Manager and Microbiologist, responsibilities included the implementation, the quality system to ISO 9001, EN 46001 and the Medical Devices Directive 93/42/EEC as well as the validation and control of an on-site ethylene oxide sterilizer.