ANDRÉ TEN NAPEL
ISO 13485 Medical Device and CE consultant
André ten Napel started his career as Mechanical Engineer in the military equipment development and manufacturing environment. He later became the Manufacturing Manager of 3M South Africa.
Since 1989, André consulted to various companies on best practice management systems and actively started consulting to medical device companies in 1993 when the Medical Device Regulations of Europe (93/42/EEC) was published.
He has assisted more than 80 Medical Device Companies in countries such as Germany, the UK, UAE, Belgium and South Africa to obtain the CE-Mark and/or FDA approval as well as more than 200 companies in obtaining ISO 9001, ISO 14001, etc.
He was responsible for setting-up a vascular catheter manufacturing operation in the United Arab Emirates, assisted with the setting-up of an infusion manufacturing operation in Portugal and was actively involved in the development of vascular stents in Germany and South Africa. He has a vast knowledge of spinal implants.
From 2005 to 2010, André owned and managed a design and manufacturing company, with 6 engineers and 40 manufacturing staff, built the company up to one of the major players and sold it in 2010. He took the afternoon off and was back in the consulting chair the next morning.
He is a Technical Expert for the Notified Body – SGS on Ethylene Oxide Sterilisation.
Andre is a very active sportsman who raced motor racing most of his life, but switched over to Duathlon Racing (running and cycling) a few years ago and was second in the South African Championships in 2013.