OUR CREDENTIALS
Certificates & Certifications
Our commitment to quality, safety and compliance is reflected in our certifications and internationally recognised standards.
01
QUALITY MANAGEMENT
ISO 13485
Certification issued to the Denex International for a successful creation and implementation of QMS(Quality Management System) for Medical Device Regulatory purpose.
02
MANUFACTURING QUALITY
GMP Compliance
Denex International is in Compliance with the Good Manufacturing Practices Guidelines.
03
REGULATORY COMPLIANCE
IMDR
Denex Manufacturing is in compliance of Schedule V under IMDR Rule 2017 of CDSCO (Indian FDA).
Relevant certificates and supporting documentation are available upon request.
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