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Testimonials

PSS UROLOGY

The medical device manufacturer

We can successful 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.

SUJANIL CHEMO INDUSTRIES PVT LTD

OTC Drugs Manufacturer

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

We have had good experience working with Operon Strategist 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

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.

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.

Operon Strategist is an outstanding medical device consulting company with whom I will do business again and these are my reasons. A true problem solver Very Reliable

Operon Strategist team of consultants provided ProvenMed, a young medical device company, with consistent and high-quality support for our successful certification effort (ISO 13485) and helped us prepare robust documentation for SFDA submission (KSA). The entire process was fully collaborative, and in the end, I had a strong understanding of the complex medical device quality management requirements and SFDA regulatory practices. They gave me, and ProvenMed, the confidence to move forward with our endeavor.

Donald has a PHD in both Computer Science and Design. His beginner course is a must see for any aspiring web professional who want to learn from the best.

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