The People Who Make It Happen

Henry Sibun

Medical Devices Consultant

• [email protected]
• +44(0) 1143 600868

Auditing medical devices to the requirements of FDA’s 21CFR820 regulations, ISO 13485 & ISO 9001.

Development, training & maintenance of RA compliance programmes. Preparing, maintenance & submission of technical documentation to regulatory bodies.

Scientific background in the medical field with comprehensive knowledge and experience of European regulation, sterilisation technologies, microbiology, manufacturing of medical devices and pharmaceuticals, quality management systems, risk management, bio-compatibility, clinical data and auditing. Senior Manager Sterilisation Expert for TÜV SÜD Group

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