TNMC Medical Devices

CE-Marking, FDA Approvals, ISO 9001 Consulting, ISO 14001 Consulting, ISO 18001 Consulting, ISO 17025 Consulting and Best Business Practice Consulting. Sterilization Validation experts - EtO, Gamma and Heat

TNMC Medical Devices UK provides CE Marking regulatory compliance consulting to manufacturers worldwide, in accordance with European Directives.

André started his career as Quality Engineer in the Armscor environment, and later became the Manufacturing Manager of 3M South Africa. For 17 years, André consulted to various companies on best practice management systems. He has assisted over 40 Medical Device manufacturers 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 and/or ISO 14001. From 2005 to 2010, André managed a design and manufacturing company, with 6 engineers and 40 manufacturing staff, in the telecommunication equipment industry as co-owner and CEO.

Ilse studied B.Cur and later completed her M.Cur in occupational health. Ilse managed Occupational Health Centres before going into consulting. Over the past 17 years she assisted various laboratories on Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) and obtained ISO 17025 certification for more than 10 laboratories