A Medical Device consultant that helps you grow your business... Contact Us Sinnov8 brings decades of experience in medical device design to the early stages of development. Contact Us

Why Choose Us

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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

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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.

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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.

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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 regulatory clearances for over 25 devices through CE/FDA approvals and more than 100 devices through CDSCO.
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

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

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

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

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

Our Expertise

Engineering solutions

Regulatory strategies

Business Consulting

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

Our Team

Mahananda

Software Engineer

Nupur Agrawal

Senior Manager Sales & Marketing

Praveen

VP- Business development

Kanika Sharma

Recruitment specialists

Jeeva Lakshmi R

Software Engineer

Monisha

Business development executive

Guddeti Sandya Rani

Regulatory specialist

Sameeksha Anand

Software Engineer

Request a Call Back

    Contact Info

    INDIA Office

    Binnamangala, , 2nd Stage,
    Indira Nagar, Bengaluru,
    Karnataka 560038, INDIA

    Telephone

    +91 96508 49955

    contact@Sinnov8.com

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