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Medical Device Assembly and Quality Testing Service

Olgiate Olona, Italy

100% product testing and quality assurance for manufactured medical devices. Ensures compliance with biocompatibility standards and absence of latex, DEHP, and pyrogens.

Manufactured by

Olgiate Olona, Italy

DIFFUPLAST is family company founded in 1976, where technology and quality meet to create customized and innovative devices for customers needs, 100% made in Italy. For nearly 50 years, Diffuplast has been producing medical devices for nutrition made to meet the specific requests of customers and to meet the quality and safety standards that the sector requires. The continuous improvements have the aim to expand the business and Diffuplast is now present in the biotech, pharma and life science sector as supplier of products for fluid management. At our factory we understand the importance of quality and reliability in the medical device industry. Thats why we follow strict regulatory guidelines, conduct rigorous testing and inspections, and continuously improve our processes to meet the ever-changing needs of our customers and the market. Our facility is certified according to ISO 13485 quality management systems and MDSAP for the Canadian market. Devices for nutrition are CE marked and manufactured in compliance with the Medical Device Directive (MDD) since 1995. Starting from 2024 Diffuplast, produces parenteral devices according to the EU Medical Device Regulation (MDR).

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