Operon Strategist

Operon Strategist work to Consult for Medical devices approvals and Turnkey projects management and setup. With strong Experience of 13 Years Operon provides consultation in below specific services...

1) Turnkey Project (Setting up Manufacturing facility - Layout preparations, machinery guidance, QMS and Trainings and Regulatory approvals)

2) US FDA Approval

3) CE marking approval

4) SFDA approval

5) UKCA approvals

6) Other all Asian, GCC, African, LATUM etc. countries approvals

7) E-QMS services

8) QMS as per ISO 13485

9) Annual maintenance service

10)CDSCO Registration for Import and Manufacturing licenes in India.