GB Soluzioni
GB Soluzioni is a certified partner specializing in medical devices consulting, MDR EU/2017/745 implementation, process and software validation, statistical support, and machinery directive application. With over 15 years of experience, a focus on quality, and a commitment to customer satisfaction, they provide comprehensive services including laboratory testing, process validation, and rapid prototyping. Their mission is to support companies in improving quality management, product design, and compliance, aiming to be a global partner for product, process, testing, and machine development.
Industries
Nr. of Employees
small (1-50)
GB Soluzioni
San Felice Sul Panaro, Emilia-Romagna, Italy, Europe
Services
Consulting services to assess and document conformity with the EU Machinery Directive (2006/42/EC).
Regulatory and engineering consulting for medical device design, CE marking support and technical documentation.
Design and execution of validation plans for production processes in the biomedical field, including packaging validation and process qualification.
Validation services for software used in regulated products, covering test planning, execution and compliance documentation.
Laboratory testing including dimensional measurements, torque and force tests, mass/weight checks, flow and leak testing, tensile tests and small-bore connector verification.
Prototype production to support design iterations and early validation testing.
Consulting services to assess and document conformity with the EU Machinery Directive (2006/42/EC).
Regulatory and engineering consulting for medical device design, CE marking support and technical documentation.
Design and execution of validation plans for production processes in the biomedical field, including packaging validation and process qualification.
Validation services for software used in regulated products, covering test planning, execution and compliance documentation.
Laboratory testing including dimensional measurements, torque and force tests, mass/weight checks, flow and leak testing, tensile tests and small-bore connector verification.
Prototype production to support design iterations and early validation testing.
Expertise Areas
- Regulatory compliance for medical devices (MDR and CE marking)
- Quality management systems (ISO 13485:2016)
- Process validation and production qualification in biomedical manufacturing
- Physical testing and dimensional metrology
Key Technologies
- Dimensional metrology
- Torque and force testing
- Mass and weight measurement
- Flow and leak testing