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Regulatory Affairs

Define regulatory strategies to place devices on regulated markets. Prepare technical documentation for regulations such as Indian MDR, EU MDR, US FDA 510K.

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Clinical Trials & PMCF

Prepare clinical evaluation reports for submission to regulatory bodies. Design and implement clinical trials and PMCF

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QA & Regulatory Support

Implement and maintain a quality system as per applicable regulatory requirements. upport to update documentation including Technical Files, Quality Manuals, Procedures, Protocols and Formats

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Welcome to Alceon

A Division of Eupraxia Centre For Clinical Excellence LLP

Alceon was founded to fill the gap of providing genuine consulting support to medical device manufacturers who want to tap the world market. During their professional stints, the two founders of the organization found a dearth of consultants who are knowledgeable, have the requisite industry experience and who can guide manufacturers without following a 'template' and 'copy-paste' approach.

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Our Services

A Division of Eupraxia Centre For Clinical Excellence LLP

Regulatory Affairs

Define regulatory strategies to place devices on regulated markets.

QA & Regulatory Support

The QA function performs immensely critical duties in medical device companies

Post Market Surveillance Service

Post Market Surveillance is the single most crucial activity that an organization

Trainings

We can provide you both online and onsite training on a variety of subjects concerning regulatory

Design & Development

We at Alceon can provide you with the support to maintain your design and development files

Biosafety Evaluation

Biological evaluation of a device is a critical design consideration for manufacturers.

Our Leadership Team

A Division of Eupraxia Centre For Clinical Excellence LLP

Atonu Dutta

(Co-Founder & CEO)

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 medical devices 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 EU Medical Device Directive, ISO13485 and MDSAP. He also holds a post graduate management qualification from the Indian Institute of Management (IIM) Indore.

Dr. Prashant Kirkire

(Co-founder)

A Ph.D. in Statistics and a post-graduate from MSU Baroda and the Indian Institute of Management Bangalore, he has over 30 years of experience in the industry. He chaired the Council for Clinical Data Management, Biostatistics and Medical Writing at ISCR between 2015-2018. He is the founder of Eupraxia and had held senior management positions in Pfizer Global R&D, inVentiHealth and IQVIA.

Our Newsletter

A Division of Eupraxia Centre For Clinical Excellence LLP

New Regulatory Requirement for Biological Evaluation & Medical Device Vigilance System

Biological evaluation now includes not just devices which come in contact with the patient, but also devices that come in contact with the user for the purpose of providing protection.

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Usability Engineering and Testing & US FDA Regulations - a primer

Usability is however a component of User Experience (UX) Design. A product's usability depends upon how well its features accommodate user's needs and contexts.

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Risk-based supplier management & Sterile Packaging Requirements

This risk-based approach in managing suppliers begins at the supplier selection stage and is an ongoing process through selection, monitoring and re-qualification.

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Contact Us

A Division of Eupraxia Centre For Clinical Excellence LLP

+91 99250 23428

info@alceon.in

201-203, Tilak Complex, Pizza Bell–Midtown Heights, Near Vallabh Chowk, Jetalpur Road, Vadodara-390007. Gujarat, India.