Contact Andre – andretn@tnmc.biz | ‭+27 (82) 892-2133‬

Andre ten Napel | Zwartkops Raceway
André ten Napel (B.Eng – Mech); NHD (QA

André started his career as Engineer in the military equipment development and manufacturing environment.

He later became the Manufacturing Manager of 3M South Africa.

For 32 years, 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 is considered as one of the leading experts in the world on Medical Device Regulatory Compliance.

He has assisted more than 100 x 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 other certifications such as Medical Testing Laboratory Standards, In Vitro Diagnostic Directive, Construction Directive, Pressure Equipment Directive, etc.

He was responsible for setting-up a vascular catheter manufacturing operation in the
United Arab Emirates and had it validated at approved by the FDA as well as CE-Marked for Europe.

Andre assisted with the setting-up of an infusion manufacturing operation in Portugal and had it validated at approved (CE-Marked) in Europe

Andre was actively involved in the development of vascular stents in in Germany and South Africa and had it validated at approved (CE-Marked) in Europe.

He has a vast knowledge of spinal implants and co-owns and manages a spinal implant company.

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 use to conduct certification audits at medical device companies on behalf of the Notified Body DQS, however having consulted widely there were too many conflicts of interests that he decided to focus on consulting.

He is a Technical Expert for the Notified Body – SGS on Ethylene Oxide Sterilisation.

Andre’s United Kingdom Company TNMC Medical Devices UK and lately Croatian Company TNMC Devices serves as Authorised Representative for companies outside Europe on the CE- Mark.

Andre is a Director of a number of biotech and/or Medical Device Companies either executive or non-executive responsible for Regulatory Compliance and Quality.