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Highlights at a glance
✓Brand: IQZYME Medtech
✓Made in Tirunelveli, TN, India
✓Certified: ISO 13485-certified, DSIR-approved R&D unit, Certified startup by the Indian government
About this item
Expertise in design, development, quality assurance, and regulatory affairs for medical products
Specialized services for CE Marking (EU MDR/IVDR), US FDA Registration, and CDSCO Licensing
Turnkey project consultation and ISO 13485:2016 consultation
Description
IQZYME Medtech Pvt Ltd is a medical technology and quality consulting company involved in the strategic areas of design, development, quality assurance and regulatory affairs of wide array of medical devices, diagnostics, drugs, surgical products, and cosmetics.
Specialised Services
CE Marketing of Medical Devices and IVDs- (EU MDR 2017/745 & EU IVDR 2017/746)
US FDA Registration (US Agent Services, US FDA Establishment Registration and Device Listing, FDA Pre & Post Audit Support, 21 CFR 820 / GMP Implementation)
CDSCO Licensing
Turnkey Project Consultation
ISO 13485:2016 Consultation
GeM Portal Registration
BIS Certification Services
Key attributes
Brand
IQZYME Medtech
Place of origin
Tirunelveli, TN, India
Certificates
ISO 13485-certified
DSIR-approved R&D unit
Certified startup by the Indian government
Reviews
Questions & answers
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