Welcome to Operon Strategist

Medical Device Regulatory Consultants in South Africa

Best medical device regulatory consultants in South Africa. We provide medical device project consluting, manufacturing designs, system implementation, training, licensing, regulatory approvals, and certifications for South Africa.

Leading Medical Device Consultant
for South Africa

Operon Strategist is a medical device consulting company providing services in South Africa. Our flagship services are to design a complete manufacturing plant for medical devices.

Our global presence caters to clients from around the globe & includes small start-ups to the world’s renowned medical device manufacturers. We have a team of expert medical device consultants whose knowledge & experience helps them handle clients both small & large.

We also provide medical device consultation for IndiaSaudi Arabia, Egypt, the USA, Costa Rica, Oman, Iran, and the United Kingdom. For free consultation Contact us now.

Get in Touch for your medical device consulting enquiries

SAHPRA, FDA, CDSCO and CE.

Medical Device Project and Regulatory Consulting in South Africa

CE MARKING
Manufacturing Facility
MANUFACTURING FACILITY
FDA
FDA 510k
validation-doc-1
VALIDATION DOCUMENTATION
clean-room-guidance1
CLEAN ROOM GUIDANCE
ISO 13485

Testimonials

5/5
“We have had good experience working with OperonStrategist the Medical Device Consultant, The team is experienced, Knowledgeable, result oriented, committed and professional in training and execution of the project, We strongly recommend Operon Strategist for all the services”
operon strategist
Arun Kumar - Director
MP Qatar Trading, Qatar
5/5
“Operon Strategist is an outstanding medical device consulting firms with whom I will do business again and these are my reasons. A true problem solver Very Reliable”
operon strategist
Zak Kouloughi - President
Tradeline Medical Lab, USA
5/5
The Team at Operon Strategist is reliable to work with & they provide excellent regulatory consultancy. They provide round the clock support & all their efforts are much appreciated.
operon strategist
Dr Apurv Patwardhan - Director
Australian Orthopedic Pvt. Ltd, India

What Our Client Says