Who
we are

Overview

01


Over 15 years’ experience in biomedical engineering consulting, inspired by our Core Values and Ethics.

02


Partnerships with major players in Mirandola’s Biomedical Valley and international reference with customers from Europe, America, Middle East and China.

03


Flexible and expert team leaders working together to achieve customer satisfaction and international regulations compliance.

04


Quality Management System ISO 13485 certified to improve customers MDR compliance process and medical devices CE marking.

05


Thousands of medical devices components measured with high performance and long-term reliable instruments for dimensional metrology.

06


Hundreds of small-bore connectors tested to assess ISO 80369 compliance.

07


State-of-the-art statistical methodologies to achieve the correct data interpretation and to suggest the right corrective actions.

08


Helping customers to apply CE marks on equipment, providing documentation in more than 10 languages.

Vision

Our vision is embracing the future and be a global partner for products, processes, testing and machines development

Mission

Our mission is to be a partner for customer problems solving and for support companies improving quality management, product design and testing, processes design and performance, equipment construction and documentation, and company’s control over them

Core Values

  • Experience, flexibility and reliability
  • Customer satisfaction
  • Continuous
    skill development
  • Commitment
  • Knowledge transfer to customers

Vision

Mission

Core Values


Our
team

Enrico Gatti

General Director

Simona Rutigliano

Quality Assurance Manager
& Laboratory Manager

Andrea Bertolazzi

Healthcare Manager

Nadia Savo

Accounting & HR Manager


Discover
our services

Machinery
directive

Medical
devices

Process
validation

Software
validation

Physical
testing

Rapid
prototyping

Statistical analysis
and training


Our
laboratory

GB Soluzioni Laboratory provides you
with high-quality services.

Dimensional
measurements


Torque
and force


Mass
and weight


Small-bore connectors
testing ISO 80369


Flow
and leak


Discover more