#1 Medical Device Consulting Company in India

A Medical Device consultant that helps you grow your business...

Sinnov8 brings decades of experience in medical device design to the early stages of development.

Why Choose Us

Team of Subject Matter Experts

We are a dedicated team of experts specializing in technology (Software, Mechanical, and Electrical), as well as in Global Regulatory (US, UK, Europe, Australia, Japan, Canada) and Quality compliance. E.g. ISO13485, MDSAP

End-to-End Product Development

We provide comprehensive support throughout the entire product development lifecycle. From concept development to manufacturing, we ensure all requirements are met for the successful launch of your medical devices.

Strategic Partnerships for Global Expansion

We have established strategic partnerships with notified bodies, agents, and authorized representatives for CE certification and U.S. FDA approvals, enabling smooth global market entry.

Robust Ecosystem of Partners

Our extensive network includes trusted partners for clinical evaluations and investigations, product testing (such as product safety, biocompatibility, etc.), testing labs, UI/UX design, prototyping, and manufacturing.

About Us

Medical Device Consultancy

At Sinnov8 Technologies, we are a team of subject matter experts with over two decades of experience in the industry. Each founder brings deep knowledge and extensive expertise in various medical technologies and world-class Quality Management Systems, enabling us to help you develop safe, effective, and affordable products.

Our mission is to empower medical device manufacturers, to create world-class products right here in India.

We have successfully facilitated various regulatory approvals, including FDA and CE certifications, for numerous clients.

With an unwavering commitment to excellence, a deep understanding of regulatory landscapes, and a relentless focus on quality, we have established ourselves as a trusted partner for organizations seeking to launch innovative and compliant medical devices in global markets.

Our Services

Product Development

End-to-end support from design to manufacturing for market readiness.

RA / QA Services

Expert guidance for CE/FDA/CDSCO approvals and global compliance.

Staffing Services

Skilled professionals in Regulatory, Quality, Product development, and Project/Program Management.

Training

Customized training solutions to empower your team with industry knowledge and skills.

Our Expertise

Engineering solutions

Regulatory strategies

Business Consulting

Get Started

Facts About Us

60 + Years

Combined expertise in Medical Devices

100 + Devices

Cleared for CDSCO/CE/US FDA

100 %

Regulatory Success

3 Offices

Global Presence

Customers Reviews

Excellent training session on ISO13485 conducted by Sinnov8 team. Sinnov8 team very knowledgeable and professional in whatever they do. Highly recommend to others.

M.R. Shakti Prakash

MR, Fibroheal, Bangalore, India

Sinnov8 team helped us in our 510(k) for Neonatal Ventilators. I am highly impressed with their knowledge and deep expertise of all areas of regulatory and product development.

H. Gupta

System Architect, Enmovi Ltd, U.K.

The Sinnov8 team played a crucial role in securing our MDSAP certification for our new plant in India. They meticulously managed every detail, from site finalization to the creation of detailed manufacturing drawings, ensuring every aspect of production was handled to perfection. Additionally, their expertise was instrumental in helping us obtain our CDSCO Manufacturing License. We truly appreciated their thoroughness and commitment to excellence

Mr. Sagar

M.D. Canada Pessary Inc, Canada