Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant - Employees, Business, Industry & CEO

Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant was founded in 2012.

Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant headquarters are in Pune, Maharashtra, India.

Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant has 143 employees.

Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant is in business consulting and services sector.

Yes, Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant is a private company.

Operon strategist is working towards catalyzing and ensuring the strategic development of the clients in the areas of regulatory approvals , quality assurance, quality control, licensing for the medical devices industry. we undertake turn key projects, annual regulatory contract as well as functions on the customized packages as per the need of the client. medical device project consultancy services with 20+ years of experience in handling regulatory projects strong knowledge of medical device regulatory and primary packaging regulations , expertise in the medical device layout design ,clean room design and process validation , medical device design and development , medical device regulatory consultant, medical device turnkey project, clinical research and quality assurance. we provide turnkey project and regulatory consultancy services worldwide .we provide 50+services in healthcare sector. we have successfully handled 60+projects related to medical device manufacturing industry and 30+ projects are the turnkey projects by include layout design ,clean room design , facility plant setup design & process validation. regulatory experience in medical device manufacturing industry /primary packaging industry. we provide regulatory consultant service for iso 9001, iso 13485, we have successfully handled regulatory project for ce marking ,usfda, usfda 510(k),21 cfr part 820 , fda, gmp, anvisa ,tga ,and client audits towards gmp certification & product registration. efficient and effective relationship management with client , communication skills with ability to lead & key influencers role in regulatory affairs, regulatory compliance systems, audits and quality assurance. our company specialties: regulatory affairs, regulatory compliance, audits & compliance, quality assurance, qualification/validation ,medical device design and development. handling medical device post marketing support include clinical evaluation ,capa management ,audit report and compliance.

Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant specialises into Medical Device Turnkey Project Consultant, Plant Layout Design Consultant, Clean Room Design Consultant, Us Fda Consultant, Ce Mark Consultant, Iso 13485 Consultant, Iso 15378 Consultant, Primary Packaging Project Consultant, Us Fda 21 Cfr Part 211, Us Fda 21 Cfr Part 210, Us Fda Registration, Cdsco Import License, Fda Consultant, Us Fda 510 K Clearance, Fda 510(k), Tga Registration, Anvisa Registration, Design And Development Of Medical Devices, Combination Device Manufacturing

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