From concept to market commercialization. We do it all.

Your Complete Service Global Regulatory, Design, Compliance & Quality Consultancy

Every idea is a great idea! What it needs is a strong regulatory, quality, clinical and product partner to get it to the market and keep the quality product on market with any compliance issues. Kite Medtech Consulting is more than just a Clinical, Regulatory and Quality service provider; we are a trusted partner that works with our clients to ensure continued success. 

About Kite Medtech

Kite Medtech Consulting is comprised of talented Engineers, Project Managers, Researches with Notified Body and FDA backgrounds. Being Regulators ourselves, we understand what is exactly needed by the Regulatory bodies such as BSI, FDA, Health Canada, TUV-SUD etc. We strive hard to bring your product to market and continuously keeping a quality product on market without any compliance issues. 

 

We aspire to strive to be of extreme value to our clients everyday. We serve with integrity, sincerity, and professionally on all your projects. We understand tight timelines, and pride ourselves in delivering the projects before the due date.

We spend our time and energy strategizing next steps and how to address your regulatory, quality, design traceability, product development and documentation obstacles effectively. We can say our greatest asset is our clientele and the people!

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Specialty in Complex Medical Devices Consulting

We exclusively serve medical devices industry, from implantable products, active devices, to In-Vitro Diagnostics Devices. We do it all. We have experts in each of areas and bring unrivaled experience. 

We collaborate with all types of manufacturers from surgeons who have an idea to large manufacturers. We pride ourselves to bringing to market and commercializing products globally.

As former industry leaders and health agency regulators ourselves, we understand your need to continue running operations and reducing your compliance risks. We bring pragmatic perspectives and a long track record of solving complex regulatory, compliance, and quality challenges — as well as proactively strengthening quality while keeping costs in check.

We Are Trusted By World’s Leading Medical Device Manufactures.

Clinical Evaluation 100%
483 and Notified Body Responses 100%
CE Mark, and 510K Fillings 100%
Design and IP Services 100%
Manufacturing and Commercialization 100%
Distribution and Post Market Surveillance 100%

Need to get free consultation about scope of your project?

As mentioned earlier, our experts are well-versed in providing consultation services in all medical device aspects. We are open to any kind of project, even if its an idea or if its a mature product on market with compliance issues. Use the link below to book your appointment. 

Our Amazing Clients