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.

Clinical Trials & PMCF

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

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

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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A Division of Eupraxia Centre For Clinical Excellence LLP

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