Question 1

When was Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  founded?

Accepted Answer

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

Question 2

Where is Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  headquarters?

Accepted Answer

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

Question 3

How many employees does Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  have?

Accepted Answer

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

Question 4

What sector does Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  operate in?

Accepted Answer

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

Question 5

Is  Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  a private company?

Accepted Answer

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

Question 6

What does Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  Do ?

Accepted Answer

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.

Question 7

What does  Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  specialize into?

Accepted Answer

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.

Question 8

What is the Legal Name of Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  ?

Accepted Answer

Question 9

Is Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  an Indian Company ?

Accepted Answer

Yes, Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  is an Indian Company.

Question 10

When was Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  incorporated ?

Accepted Answer

Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  was incorporate on 2012

Question 11

What is the registered address of Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant   ?

Accepted Answer

The registered address of Operon Strategist | Medical Device Turnkey Project | Us Fda | Iso 13485 Consultant  is pune, maharashtra, india

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