Medical: CE-Marking, FDA Approvals, Medical Device Regulatory Compliance Consulting. Sterilization Validation Experts - EtO, Gamma and Heat
Food Safety: ISO 22000, HACCP
Other CE-Marking: Machinery Directive, Construction Directive
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André started his career as Engineer in the Armscor environment, and later became the Manufacturing Manager of 3M South Africa. For 24 years, André consulted to various companies on best practice management systems.
From 2005 to 2010 André owned and managed a design and manufacturing company, with 6 engineers and 40 manufacturing staff.
After 2010 he again consulted to various medical device companies on product development as well as regulatory requirements. Andre serves on the Board Of Directors of a number of Medical Device Companies.
Ilse studied B.Cur and later completed her M.Cur in occupational health.
Ilse managed Occupational Health Centers before going into consulting.
Over the past 28 years she assisted various laboratories on Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) and obtained ISO 17025 certification for various laboratories.
Ilse's years of medical device clinical experience and knowledge of ISO 14155 and MEDEV 2.7.1 is a big plus point in our Medical Device Regulatory Consulting.
Together they assisted more than 90 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, ISO 14001, ISO 17025, etc.