Our Testimonials

What Our Client Says

PSS Urology

The medical device manufacturer

We can successfully cater to the international clients to upgrade and monitor their documentation as well as their contract manufacturing sites. The clients rely on us completely for our works and our services, which make us long terms partner with them.

Australian Orthopaedic :

The orthopedic manufacturer

We have guided the new start-up company who had no clue about the setting up the facility and complying the regulations. We delivered to the expectations of the client and regulators successfully.

Incredible 3D Implant

Manufacturer of medical device

We guided the established industrialist to enter in the medical devices manufacturing segment, with the first of its kind device and achieved the certifications beyond the expectations of the client.


OTC Drugs Manufacturer

We upgraded the existing plant, QMS documentations, documentation to meet the USFDA expectations and client could successfully come up with flying colours in USFDA inspection.

Do you have a medical device to launch?

Please Read More

Testimonial - MP Qatar Trading

Arun Kumar, Director MP Qatar Trading, Doha, Qatar

We have had good experience working with Operon Strategist. The Team is Experienced, Knowledgeable, Result oriented, committed and professional in training and execution of the project. We strongly recommend Operon Strategist for all their services.
Testimonial - Medtronic

Rahul Paith, Project Manager, Medtronic India

We hired Operon consultant as a subject matter expert for overseeing sterilization activity by adhering to the protocol and for reviewing results and reports in line with global standards and our requirements for the commercial launch of a product in the global market. The team exceeded our expectations by providing quality outcome and played a vital role to launch the product in time.
testimonial - Cilicant

Manish Jain, CEO, Cilicant Chem Pvt. Ltd., Pune, India

The Efforts of Operon Strategist in helping us resolve our various regulatory queries have been outstanding. Their expertise & regulatory knowledge puts them on par with other globally recognized regulatory consultants.

Zak Kouloughli, President Tradeline Medical Lab, USA

Operon Strategist is an outstanding consulting company with whom I would do business with again, and these are my reasons:

  • A true problem solver
  • Very reliable


Dr Apurv Patwardhan, Director Australian Orthopedic Pvt. Ltd, India

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.

Our Services

Manufacturing Site Design and Conceptualization

Medical Device Certification and QMS

Medical Device/Drug-Device Combination Product Design & Development

Medical Device Post Marketing Support