Alceon
Medtech Consulting

AMC was founded with a mission to help our clients in the medical device and in-vitro diagnostic device sectors to navigate the complex regulatory landscape and obtain the necessary approvals to bring their products to the market.

Helping Medical Device Manufacturers to Achieve Regulatory Compliance and Market Access.

We don’t stop at just writing your documents! Our team is available to provide personalized support throughout your application process, to guide you in areas such as classification, validation, testing and to respond to queries from regulatory agencies.

Featured Services

News & Announcements

Risk Management Workshop

We successfully completed an online risk management training programme that saw overwhelming participation from several manufacturers located at different locations in the country.

Product Launch
Alert

We are happy to announce the launch of our eQMS software – POLESTAR – A software that’s designed in collaboration with software developers and domain experts.

ORTHOFOCUS
meet up

We successfully conducted an online webinar for orthopaedic manufacturers. The webinar was conducted by experts from the...

Our Vision

What do we want to be

To be a niche provider of regulatory consulting solutions and known for its quest for excellence

Our Vision

What do we want to be

To be a niche provider of regulatory consulting solutions and known for its quest for excellence

 

Our Mission

What do we want to be

Deliver innovative and creative solutions that empower medical technology manufacturers to achieve regulatory compliance and drive continuous improvement

Our Mission

Deliver innovative and creative solutions that empower medical technology manufacturers to achieve regulatory compliance and drive continuous improvement

Our Mission

Deliver innovative and creative solutions that empower medical technology manufacturers to achieve regulatory compliance and drive continuous improvement

Core Values

Creativity Thinking

Have a mindset to provide creative, out-of-the-box solutions

Continuous Learning

Make continuous learning and upgradation of knowledge our best friend

Quality Consciousness

Never compromise on quality

With nearly three decades of professional experience, my journey began in the heart of industrial operations, spanning engineering, production, maintenance, and quality roles across sectors such as manufacturing, chemicals, and infrastructure. For the first fifteen years of my career, I had the opportunity to work with leading organizations, where I learned the value of delivering quality and crafting out-of-the-box solutions to complex business challenges. These formative years laid a strong foundation in problem-solving and operational excellence, principles that have continued to shape my approach even as I transitioned into the highly specialized world of medical devices and regulatory affairs.

Atonu Dutta

founder & CEO

We’d Love to Hear From You!

Whether you have a question, feedback, or just want to say hello, feel free to get in touch. Our team is ready to assist you.

Careers

WE ARE HIRING !

REGULATORY AFFAIRS CONSULTANTS/QMS CONSULTANTS /SCIENTIFIC WRITERS

Please apply if you want to join our vibrant team

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