Welcome to Operon Strategist

Medical Device Consultant for Germany

Operon Strategist is a trusted medical device consultant offering specialized regulatory consulting services for medical device manufacturers in Germany. We provide complete solutions including turnkey services, CE Marking support, ISO 13485 implementation, FDA 510(k) submissions, system implementation, licensing, regulatory approvals, and certification support tailored for the German market.

Let's Get Started

Turnkey Project Consultants

Regulatory Approvals

Leading Medical Device Consultant for Germany

As one of the premier medical device consultants in Germany, Operon Strategist helps manufacturers navigate the complex regulatory environment, including EU MDR compliance, CE Marking, and ISO 13485 Quality Management System implementation. We also support international market approvals such as FDA 510(k), SFDA, EDA Registration, and CDSCO registrations.

Our consulting services are designed to help you establish world-class manufacturing facilities, achieve regulatory certifications, and secure faster market access in Germany and across the EU.

Get in Touch for your medical device consulting enquiries

CE marking, US FDA 510(k)and CDSCO registration!

About Operon Strategist – Experienced Medical Device Consultant in Germany

With over a decade of regulatory expertise, Operon Strategist is a trusted medical device consultant helping manufacturers successfully navigate the complex German and European regulatory landscape. Our experienced team specializes in CE Marking, EU MDR compliance, ISO 13485 QMS, and FDA 510(k) submissions, supporting both startups and established medical device companies in achieving fast, reliable market access.

Our proven track record spans multiple countries including Germany, India, USA, UK, South Africa, Costa Rica, Oman, Netherlands, Algeria, and Saudi Arabia, making us a dependable regulatory partner for businesses worldwide.

Medical Device Regulatory Consulting Services For Germany

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”

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”

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.

Dr Apurv Patwardhan - Director

Australian Orthopedic Pvt. Ltd, India