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ISO 13485
FDA 510(K), PMA, De Novo

ISO/IEC 13485:2016 is an International Standard that specifies requirements for a Quality Management System (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 13485 Consultation

Medical Device QMS

ISO Certification

ISO is the International Organization for Standardization, an international standard-setting body that facilitates common standards across nations.


Establish Global QMS

Companies need to establish a Quality Management System (QMS) on a global scale.

510(K) Clearance, PMA/DeNovo Approvals

Help with the FDA process

ISO 13485 or FDA 510(K)/PMA/DeNovo CONTACT FORM

Tell us about yourself and we will reach out to you to provide cost effective ISO 13485 or FDA 510(K) /PMA/DeNovo solutions. 


222 W Merchandise Mart,
Suite 1212, Chicago, IL 60654,

Compliance Office:
c/o. Sicherten,
Plot 243, Sardar Patel Nagar,
Kukatpalli, Hyderabad - 500085,

Software Development Office:
c/o. Nichetech, 
409, Sheetal Varsha,
Shivranjani Cross Road, 
Ahmedabad - 380015,


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