Welcome to Operon Strategist

Medical Device Consulting For Germany

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

Leading Medical Device Consultant for Germany

Operon Strategist is a medical device consulting company for Germany that provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals, and certifications. We provide clients with customized solutions to manufacturers looking to set up a world-class manufacturing unit.

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 India, Saudi Arabia, the USA, the UK, South Africa, Oman, Iran, Egypt, Germany and Netherlands. Feel free to contact us.

Get in Touch for your medical device consulting enquiries

FDA, CDSCO and CE.

Medical Device Regulatory Consulting Services For Germany

CE MARKING
manufacturing facility
MANUFACTURING FACILITY
FDA
FDA 510(K)
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