AXXION Regulatory Advisory

Gustavo Abdala
Electrical Mechanical Engineer

FOUNDER & GENERAL MANAGER

Director and founder of Axxion since 2009. He gained experience performing regulatory and quality roles for different companies in the medical products industry. Lead auditor ISO 13485 and ISO 9001. Quality expert in regulatory affairs for medical devices.

Agnese Martinelli
Biomedical Engineer

INSTITUTIONAL RELATIONS

Partner at Axxion since 2010. Trained in regulatory affairs since the beginning of her professional career and specialized in defining regulatory strategies. She works as a Professor at the Biomedical Engineering School at National University of Córdoba, since 2011. In frequent contact with regulatory agencies and and local industries, through her participation in CAISAL, the local chamber of the life sciences industry.

María Laura Vega
Biomedical Engineer

PROJECT LEADER

Member and partner of Axxion since 2017. Specialized in medical devices design based on regulatory requirements, specifically for medical electrical equipment. Responsible for finding solutions from the design, to approve laboraty testing, guaranteeing the compliance with safety and performance requirements

For Manufacturers, Importers and Distributors of Medical Devices.

QMS development and certification
QMS audits under regulations and standards applicable to the medical industry.

QMS auditors
Design Requirements for product development.

At LATAM health authorities, FDA for USA and CE marking for EU.

Technical File documents development. Risk Management File, Usability File, Software Lifecycle File, Clinical Evaluation File, User Manual, Labeling, among others.

Technical advice for design, documentation and tests in accordance with international medical devices standards ISO 14971, ISO 10993, IEC 62304, IEC 62366, IEC 60601, ISO 80601, among others.
Management with testing laboratories and notified bodies.