Andrea Bertolazzi's Contact Details

Andrea Bertolazzi's Company Details

GB Soluzioni

Medolla, Emilia-Romagna, Italy • 26 Employees
Medical Devices

GB Soluzioni is your partner for Medical Devices Directive 93/42/EC, 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.GB Solutions SRL was founded in 2007 by an idea of Enrico Gatti, current CEO of the company. After years of managerial experience gained in global healthcare companies, he decided to offer support and consulting to improve the production processes and to raise the quality standard, as well as the management of safety, of machines and plants.In its decennial experience the company has supported the most important players in the healthcare district of Mirandola and subsequently, driven by the desire to grow and expand its market, it became a partner of global healthcare firms and companies that operate in areas such as:– Automation– Packaging– Food– Automotive– etc.Currently, 6 out of top ten global healthcare companies (2018 data) use GB Soluzioni as partner.GB Soluzioni offers consulting in:– Process Validation and Verification• Technical Files - DHF• Process Validation• GMP• Lean Manufacturing• Software Validation• Process improvement– Medical devices directive• Device prototyping• Quality Manual• Risk Analysis• CE marking– Machinery Directive• User Manuals• Risk Analysis and PL calculation• Safety consulting during automation design– Physical Measurements