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 is to be a differentiator in the regulatory consulting and training space, by providing services that shall delight the customer
Creative, out-of-the-box solutions to solve the customer's problems
Continuous upgradation of knowledge and skills to provide the best-in-class services
Create synergies through collaborations with external expert pool like other like-minded consultants, subject-matter experts, and academia
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.
An electrical engineer and a Masters in Mathematics from the Birla Institute of Technology; Science (BITS) – Pilani, he has over a decade of experience of working as an auditor and assessor of medicaldevices for a prestigious European Notified Body. He did audits for a large variety of medical devices, both active and non-active in over 75 companies, for the European Union Medical Device Directive, ISO13485, and MDSAP. He also holds a postgraduate management qualification from the Indian Institute of Management (IIM) Indore.
founder & CEO
