IQZYME MEDTECH PVT. LTD.

Catalyzing Quality, Innovation & Compliance

WELCOME TO

IQZYME!

We are a medical technology and quality consulting company which involves in the strategic areas of design, development, quality assurance and regulatory affairs of a wide array of medical devices, diagnostics, drugs and molecules of research interest. We partner with manufacturing industry, start-ups, research groups and educational institutes with a vision to effectively translate their ideas to fully developed products that are ready for commercialization.

Our Vision

To be the leading global consulting company providing quality assurance and technology consultation that catalyses our customers' quest for better quality, compliance and innovation.

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Why Us?

At IQZYME we make the entire experience of consultation a hassle free experience for our clients.

We have a team of industry experts who provide excellent services at affordable cost. We work in tandem with our customers to ensure that they meet the present global regulatory and quality standards and achieve 100% compliance.

We incorporate scientific and commercial strategies to provide on-site and off-site consultation in optimizing the entire product lifecycle, managing resources and risks and assist them in achieving the regulatory clearances and quality standards. We promise excellent documentation services, regulatory and quality support, post certification services and fast turnaround in project completions.

Our Services

Turnkey Project Consultation

IQZYME keeps highest professional standards in providing the following services as part of Turnkey Project Consultation to our Customers.

CDSCO Approvals & New Product Development

We provide the consultancy in regulatory affairs in the areas of Medical Devices and In-vitro Diagnostic Kits pertaining to the..

ISO 13485:2016 Consultation

We provide the following end to end support to customer for implementing and getting certified to ISO 13485:2016 QMS.

ISO 9001:2015 Consultation

We provide the following end to end support to customer for implementing and getting certified to ISO 9001:2015 QMS.

CE Marking

IQZYME provides the following support to customer for compliance with EU Directives and for obtaining / affixing CE Marking.

"We want to express our appreciation for IQZYME's guidance and assistance in helping us achieve regulatory clearances from CDSCO for our new facility and products. IQZYMES's in depth understanding of international standards such as ISO 13485:2016 and 93/42/EEC tremendously helped us to improve and optimize our processes. The training imparted to our staff by their IRCA certified lead auditors helped us to implement ISO compliant quality management system in our facility. We are completely satisfied with the service we receive from IQZYME."

Arun Jyothi S P

Managing Director, Alicorn Medical Pvt Ltd, Trivandrum

"It was a great experience to work with IQZYME for the CE certification of our diagnostic products. IQZYME provided great support in documentation of technical data and compliance of procedural formalities and provided diligent follow up of our application till CE marking was obtained. Their consultants were wonderful and most affable people to work with."

Dr V I Bishor

CEO & MD, ubio Biotechnology Systems Pvt Ltd, Cochin

"I had the pleasure of working closely with team members of Iqzyme. Without a doubt, you've put together a wonderful team at Iqzyme. Your team's excellent technical knowledge, reliability and consistency make you a regulatory consulting firm with outstanding professional standards."

Reeja Thomas

V.P-Technical, Rapha Diagnostics Pvt. Ltd., Palakkad

"I had the opportunity to work closely with the qualified professionals of Iqzyme as a part of updating ISO 13485:2016 compliant QMS in Yucca Diagnostics. Their entire team was committed to bridge the gaps in the theory and practice of QMS by imparting excellent training to our employees. I highly appreciate Iqzyme Medtech for their quality, commitment and professional approach."

Sambhaji Patil

Managing Director, Yucca Diagnostics, Kohlapur

"As a pharmaceutical quality assurance consulting firm, IQZYME has a professional, straight forward and creative approach in implementing quality management systems. They encourage and ensure a smooth transition in to new and updated standards to keep up with ever-changing national and international regulatory scenario."

Thomas Koshy

Founder Managing Director, Angstrom Biotech Private Limited, Vadodara

Trust

We strive to earn the confidence of our customers through our quality services which will lead to customer loyalty and referral. We trust each other in the company by displaying the highest levels of integrity in our dealings and working together as a cohesive team.

Excellence

We excel in everything that we do through innovation, creativity and superior Services differentiation that sets us apart from the competition and drive our growth.

Respect

We respect our customers, employees, our business partners, society and all other stakeholders. We show consideration for one another. We respect each other's differences. We treat everyone with dignity.