GB Soluzioni is your ISO 13485:2016 certified partner for

Medical Devices Directive 93/42/EC and MDR EU/2017/745 consulting, Process Validation, Software Validation, Lean Manufacturing, Physical Measurements, Machinery Directive 2006/42/EC, Rapid Prototyping

Our mission is to be a partner for customer problems solving and for support companies improving Quality Management, Product Design, Processes Design and Performance, Equipments Construction and Documentation, and company's control over them.


We provide global consulting from Design to Manufacturing

Medical Devices

We help you demonstrate your medical device is compliant with the EC directive and with new MDR EU/2017/745.

Process Validation

We help you demonstrate your process is consistently delivering quality products.

Software Validation

We help you demonstrate your software is compliant with specifications.

Lean Manufacturing

We help you eliminate waste from your manufacturing system, making obvious what adds value and reducing everything else.

Physical Measurements

Accurate and precise measurements with data analysis.

Machinery Directive

We help you demonstrate your equipment is compliant with the EC directive.

Rapid Prototyping

We build design rapidly and cost effectively.

About Us

GB Soluzioni overview, vision, mission and values.