GB Soluzioni

medical devices

About

GB Soluzioni is a consulting company based in Mirandola, Italy, specializing in biomedical engineering and medical device compliance. With over 15 years of experience, it is ISO 13485:2016 certified and serves clients across Europe, America, the Middle East, and China. The company focuses on quality management, product design, testing, and regulatory compliance for medical devices. The services offered by GB Soluzioni include guidance on Medical Device Regulation (MDR) compliance, process and software validation, and comprehensive support throughout the product lifecycle. Their laboratory provides high-quality testing services, including dimensional measurements, torque and force testing, and compliance testing for small-bore connectors according to ISO 80369 standards. The company emphasizes customer satisfaction, reliability, and continuous skill development, making it a trusted partner in the biomedical sector.

Technologies

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Keywords

life science healthcare fda consultant medical device directive laboratory software validation verification & validation automotive lean manufacturing machinery directive process validation regulatory affairs risk analysis iso 80369 connectors rapid prototyping iso 13485:2016 consulting mdr eu/2017/745 services medical device consulting ce marking small-bore connectors testing physical testing testing laboratories statistical methodologies design validation asset management software validation medical device and equipment manufacturing lean manufacturing implementation

Location

53 Via Giacomo Matteotti, Emilia-Romagna, Italy, 41036

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