Simone is an industrial pharmacist with a production, R&D and technical background, having experience in regulatory affairs, quality management, validation, intellectual property, manufacturing and productivity improvement.

Simone is a member of MDMSA, SAFHE, SAAPI and sits on the SABS technical & SAHPRA ITG committees, is a SANAS technical expert for medical devices as was extensively involved with SAMED on the regulatory, market access and local manufacturing committees over 20+years; and currently holds the position CEO / TECHNICAL QARA, CHAIRPERSON (2021-2025) MDMSA [Medical Device Manufacturers South Africa] and was CHAIRPERSON / Vice CHAIRPERSON (2022/3) MDPG [Medical Device Professional Group]. Simone also provided a medical textile market evaluation to expand textile medical devices for the SA Cotton Cluster and participated in the MRC medical device Landscape analysis.

Simone’s company Rudolph-Shortt consultancy cc trading as ISOhealthSA, offers expert consultation in food, cosmetic, disinfectant, medicine and medical device regulatory affairs; for many products and services, good manufacturing practices and quality management systems design, development and implementation, with auditing, process improvement and training to manage operational risk, achieving compliance and driving business improvement.

The company works with small to medium enterprises around South Africa and surrounding neighbouring countries, e.g Swaziland, Lesotho, Botswana in the food, beverage, cosmetics, medical device and pharmaceutical industries.
The company has earned its reputation as a leading consultation service provider with technically qualified specialists with vast practical industry experience, which includes Implementation, design or improvement of operational management, systems realising process realignment and cost savings initiatives.

ISOhealthSA has local and international experience in pharmaceuticals, toiletries, foodstuffs and medical devices regulations, quality and product safety systems, project management, occupational Health & Safety, and technical developments including process and product validation.