Compliance
Certified for RoHS-compliant manufacturing facility, ensuring the Restriction of Hazardous Substances in Electrical and Electronic Equipment.
In compliance with securing electronically protected health information (ePHI).
Capability Maturity Model Integration (CMMI) (Maturity Level 3)
Standard CMMI Appraisal Method for Process Improvement ver.1.3
Capability Maturity Model Integration (CMMI)(Maturity Level 5)
Standard CMMI Appraisal Method for Process Improvement ver.1.5
Good Manufacturing Practices (GMP)
System of regulations to produced and meet quality standards
Regulatory Approval
Registered with CDSCO for Form MD-9, a license permitting the Manufacture for Sale or for Distribution of Class C or Class D Application in FORM MD-7
Registered with CDSCO for Form MD-13, a license permitting the Manufacture Medical Devices for the purpose of testing of Class C
Registered with Form MD-42 to Sell, Stock, Exhibit or offer for
Sale or Distribute a Medical Device Including In Vitro Diagnostic Medical Device
Registrations
Certified for RoHS-compliant manufacturing facility, ensuring the Restriction of Hazardous Substances in Electrical and Electronic Equipment.
In compliance with securing electronically protected health information (ePHI).
Government e Marketplace (GeM)
Listed as OEM Panel- (Original Equipment Manufacturer)
Ayushman Bharat Digital Mission (ABDM)
Integrated: M1, M2, M3
MSME (Udhyam)
Quality Certifications
ISO 9001:2015
Quality Management System
ISO/IEC 27001:2022
Information Security Management Certified
ISO 13485:2016
Medical Devices – Quality Management Systems
