Romina Carranza Email & Phone Number

Córdoba, Cordoba, AR

At ViewMind, I established and maintain a Quality Management System (QMS) aligned with ISO 13485 and FDA standards, which led to ISO 13485 certification in December 2023, reinforcing the company’s commitment to quality.I oversee technical documentation to ensure compliance with IEC 62304 (Software Lifecycle), IEC 62366 (Usability Engineering), and ISO.

Córdoba, Argentina

I am responsible for ensuring the regulatory compliance of the product across Argentina. I manage regulatory documentation, oversee inspections, and maintain operational readiness. My efforts led to the successful re-certification of GMP in March 2023, ensuring continued compliance with regulatory requirements.

I provided guidance, fostered networking opportunities, and offered feedback to optimize the development of two innovative medical technology projects during a six-month incubation program.

Córdoba, Argentina

As a consultant, I worked with over 15 medical device companies, providing regulatory and quality guidance focused on compliance with ANMAT GMP, FDA GMP, and ISO 13485 standards. I developed tailored Quality Management Systems, conducted internal audits, and trained teams. Additionally, I supported companies during inspections and the implementation of.

Córdoba, Argentina

Inspection and oversight of healthcare facility inspections to ensure the safe use of diagnostic imaging equipment and compliance with biosecurity standards during the pandemic. Coordination of inspection teams and comprehensive management of data acquisition and processing

Córdoba, Argentina

Selling medical equipment of low, medium, and high complexity in five regions of the country. Managing clients and commercial portfolio.

Córdoba, Argentina

Activities involving management and technical assistance for medical devices across various services. Supervising preventive and corrective maintenance, verification, and equipment commissioning.

Provincia De Córdoba, Argentina

Supervised Professional Internship of the Biomedical Engineering program in the Biomedical Maintenance Service Area.

Bachelor'S Degree, Bioengineering And Biomedical Engineering

Internal Audit Iso 9001, Auditing

Auditor Interno Iso 13485, Auditing

Specialization In Medical Product Management, Design And Development, Bioengineering And Biomedical Engineering

Data Analyst