About Us

Alceon MedTech Consulting (AMC) is founded with a mission to help our clients in the medical device and invitro diagnostic device sectors to navigate the complex regulatory landscape and obtain the necessary approvals to bring their products to the market. We offer a range of services to our clients, including regulatory strategy development, risk management, clinical trial design and management, post-market surveillance, trainings and more.

Our approach is focused on delivering high-quality, practical and customized solutions maintaining highest working standards. Integrity, innovation, out of the box thinking and quest for excellence are at the core of our business, and we strive to embody them in all of our interactions.

AMC was founded with a vision to make a meaningful impact in the medical device industry. We saw an opportunity to use our expertise to help businesses overcome the complex regulatory challenges that can often hinder innovation and progress in the industry. Our goal is to provide our clients with the knowledge, support, and guidance they need to succeed in the medical device market and ultimately improve patient outcomes. 

 

 

 

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

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

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

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

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

Our Team

We pride ourselves on our team of experts who have domain expertise in different areas of the medical device industry, including design, regulatory affairs, clinical affairs and quality management. We believe in continuous learning and development. Our team stays up to date with the latest requirements of the industry and regulators to ensure that we can provide the best advice to our customers.  Coming from diverse backgrounds, and led by someone who has spent over a decade in the medical device regulatory field, our team remains committed to help customers attain their objectives for which they would have hired us.

Founder Message

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.

After earning my degrees in Electrical & Electronics Engineering and Mathematics from BITS Pilani, I began my professional journey in operations. Over time, I pursued an executive post-graduate diploma in business management from IIM Indore to complement my technical background. My transition into the medical device sector began during my tenure at DNV. I served as a Lead Auditor and Assessor, engaging in over a thousand audit man-days across ISO 13485, CE marking, and MDSAP standards. Working with a broad spectrum of medical technologies, from cardiac and ophthalmic devices to disposables and implants, strengthened my resolve to support organizations in achieving excellence in quality and compliance.

Today, as CEO of Alceon MedTech Consulting, I’m proud to lead a dynamic team of professionals dedicated to simplifying compliance and accelerating success for our clients. From technical file preparation and internal audits to training and regulatory strategy, our mission is clear: “To be a trusted partner for medical device and IVD manufacturers navigating global requirements.”

At Alceon, regulatory excellence should empower innovation, not hinder it. By blending technical depth with practical insight, we strive to deliver results that not only meet standards but elevate them.

Thank you for being part of our journey.

Atonu Dutta

founder & CEO

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