ALCEON announces partnership with Advisera
a leading solution provider for compliance toolkits, online trainings and automated software solutions.
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