Welcome to Operon Strategist

Medical Device Consulting for Egypt

We are one of the leading medical device regulatory consultants in Egypt. We offer clients an array of services like turnkey services, system implementation, training, licensing, regulatory approvals, and certifications for Egypt.

Leading Medical Device Consultant for Egypt

Operon Strategist is a premier medical device consulting firm dedicated to empowering manufacturers in navigating the complex regulatory landscape in Egypt. Our expert regulatory guidance is tailored to support the strategic development of healthcare manufacturers, with a particular focus on EDA registration.

Our Comprehensive Services Include:

  • Turnkey Services: We offer customized solutions designed to help manufacturers establish world-class production facilities that meet all regulatory standards.

  • System Implementation: Our team provides seamless integration of regulatory systems, ensuring your operations comply with local and international regulations.

  • Training & Licensing: We deliver tailored training programs and licensing assistance to equip your team with the knowledge and skills necessary to tackle regulatory challenges confidently.

  • Regulatory Approvals & Certifications: Benefit from our expert support in obtaining essential approvals and certifications, streamlining your path to market entry.

Get in Touch for your medical device consulting enquiries

FDA, CDSCO and CE.

MEDICAL DEVICE REGULATORY CONSULTING SERVICES FOR EGYPT

CE MARKING
FDA 510k
FDA 510(K)
EDA REGISTRATION
MANUFACTURING FACILITY
VALIDATION DOCUMENTATION
CLEAN ROOM GUIDANCE

Why Choose Operon Strategist?

With a global footprint, we serve a diverse clientele that includes startups and well-established medical device manufacturers from countries such as India, South Africa, the USA, the UK, Costa Rica, Oman, and Iran. Our team of experienced consultants possesses the knowledge and expertise to help businesses of all sizes navigate the intricate world of medical device regulations.

Ready to ensure compliance and success in the Egyptian market? Contact us today for a free consultation and take the first step towards meeting your regulatory goals.

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