Welcome to Operon Strategist

Medical Device Regulatory Consultants in South Africa

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

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Turnkey Project Consultants

Regulatory Approvals

Leading Medical Device Consultant
for South Africa

Operon Strategist is a specialized medical device consulting company offering comprehensive services in South Africa. Our flagship expertise lies in designing and setting up complete medical device manufacturing facilities, tailored to meet regulatory and operational requirements.

With a strong global presence, we support clients worldwide—from emerging start-ups to internationally recognized medical device manufacturers. Our team of experienced medical device consultants combines deep industry knowledge with practical expertise, enabling us to effectively support organizations of all sizes with reliable, compliant, and scalable solutions.

We also provide medical device consultations for India, Saudi Arabia, Egypt, the USA, Costa Rica, Oman, Iran, the United Kingdom, Germany, Algeria, and the Netherlands. Contact us now for a free consultation.

Get in Touch for your medical device consulting enquiries

SAHPRA, FDA, CDSCO and CE.

Medical Device Project and Regulatory Consulting in South Africa

Testimonials

Rated 5 out of 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”

Arun Kumar - Director

MP Qatar Trading, Qatar

Rated 5 out of 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”

Zak Kouloughi - President

Tradeline Medical Lab, USA

Rated 5 out of 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.

Dr Apurv Patwardhan - Director

Australian Orthopedic Pvt. Ltd, India

What Our Client Says