About Us
At IQZYME MEDTECH PVT. LTD., we are more than a regulatory consultancy; we are your trusted partners in navigating the complex world of medical device regulations and compliance. Headquartered in India, IQZYME specializes in providing end-to-end support to manufacturers and importers of medical devices and In-Vitro Diagnostics (IVDs), helping them achieve regulatory excellence with ease and precision.
Our Vision
We envision a future where regulatory processes are simplified, allowing medical device innovators to focus on what truly matters—enhancing patient care and saving lives.
Our Mission
Our mission is to empower businesses by streamlining the regulatory processes essential for market entry and product success. We aim to deliver high-quality consultancy services that ensure compliance, safety, and efficacy of medical devices, making healthcare innovations accessible to the world.
Our Expertise
With a team of highly skilled professionals led by seasoned industry experts, we bring unparalleled expertise in:
- Regulatory documentation and submissions.
- Design and development of active medical devices and IVDs.
- Quality management system implementation (ISO 13485).
- CE marking, CDSCO licensing, and FDA compliance.
- Software validation, product testing, and market approvals.
Why Choose IQZYME?
Proven Track Record
We have supported numerous clients in achieving timely regulatory approvals.
Tailored Solutions
We customize our services to meet the unique needs of every client and project.
Commitment to Excellence
Our rigorous processes ensure 100% compliance and satisfaction.
Comprehensive Support
We stand by you at every stage of your product’s lifecycle.
Industries We Serve
Medical Devices
In-Vitro Diagnostics
Healthcare Technology
Cosmetics
Connect with IQZYME
As the healthcare landscape evolves, trust IQZYME MEDTECH to help you stay ahead of the curve. Whether you’re launching a new product or expanding into new markets, we are here to provide you with the expertise, guidance, and solutions you need.