AXXION Regulatory Advisory

We are an interdisciplinary team of professionals specialized in regulatory compliance for the medical industry.
Our goal is to help medical devices developers and companies to improve their market position in a hard and fast-changing regulatory environment where the regulatory requirements are getting more complex to reach. Our strength lies in our wide experience, highly motivated professionals, execution and analytical skills and reliability on guiding our clients and partners through the regulatory processes.

Years of experience

180

Adviced companies

Establishment Registration

Countries Reached

Services

Establishment registration
For Manufacturers, Importers and Distributors of Medical Devices.

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

Training
QMS auditors
Design Requirements for product development.

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

Technical documentation development and technical support for compliance with safety and efficacy tests of medical devices.
Preparation of Technical File, Risk Management Report, Clinical Evaluation, User Manual and Labeling.

Design and reengineering of medical devices
Adaptation to regulatory requirements.

European Authorized Representative (EAR).
Authorized Representative services for European Union
Other services associated (Free Sales Certificates, market surveillance, incident reporting)

Companies that trust us

Contact us

Email

info@axxionregulatory.com

Phone

+54 9 351 593-9271

Axxion Regulatory

Location

Córdoba - Argentina

Send Message Whatsapp

We welcome your questions and concerns. Please fill out the following form.

Regulatory Affairs Services

Efficient regulatory strategies for medical devices

Gustavo Abdala Electrical Mechanical Engineer

Agnese Martinelli Biomedical Engineer

María Laura Vega Biomedical Engineer

Years of experience

Adviced companies

Establishment Registration

Countries Reached

Services

Establishment registration For Manufacturers, Importers and Distributors of Medical Devices.

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

Training QMS auditors Design Requirements for product development.

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

Technical documentation development and technical support for compliance with safety and efficacy tests of medical devices. Preparation of Technical File, Risk Management Report, Clinical Evaluation, User Manual and Labeling.

Design and reengineering of medical devices Adaptation to regulatory requirements.

European Authorized Representative (EAR). Authorized Representative services for European Union Other services associated (Free Sales Certificates, market surveillance, incident reporting)