Get In TouchEN|中文 Group Our Company Why Partner with Us? Products & Services News & Resources Contact us We comply with medical standards We take meeting medical standards very seriously and ensure that all of our facilities meet the highest appropriate requirements. All of our production sites for the medical field meet the International Organization for Standardization (ISO) certification ‘Medical Devices – Quality Management Systems – Requirements for Regulatory purposes’ (ISO 13485). View Certificate – Trento, Italy View Certificate – Salerno, Italy View Certificate – Bologna, Italy View Certificate – Wuxi, China View Certificate – Memphis & Cincinnati, US View Certificate – Dayton, US View Certificate – Logan, US View Certificate – Portland, US View Certificate – Providence-Logan, US As a company, we have long-term experience in providing our customers with regulatory support. We perform internal validation of products and manufacturing processes providing a high level of quality assurance. Quality and validation assured We are certified to meet ISO 13485 FDA-registered establishment: Master Files registered at FDA Manufacturing site for Medical Devices accredited c/o Japanese Ministry for Health Member of ISO and ASTM technical committees Processes and treatments designed to be validation friendly We meet CE marking specifications for medical devices (classes IIa, IIb and class III bio-resorbable) / Harmonizing standards, globally We have high quality standard process control to guarantee product conformity to the requirements agreed with our customers. The Quality System used by our different plants is harmonized as they were created using the same internal model. Importantly, all of our internal validation processes are in compliance with international regulatory guidance (EU and FDA) and the manufacturing processes we use are designed to meet FDA and CE marking specifications. We adhere to both Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) as standard across the medical division of Lincotek. We have Master Files for Devices (MAF) for our additive manufacturing services and plasma spray coatings and we support customers with the registration of their own devices worldwide in different countries such as the EU, USA, and Japan. We are accredited by the Japanese Minister of Welfare as a medical device manufacturer. / We maintain the highest standards Lincotek Medical is active members of ISO and ASTM technical committees. We follow the development and revision of standards and we can vote to approve or modify a standard related to our processes. We are always informed about the latest news on this topic, so we can ensure that we offer our customers the highest standard of service. / Help registering your device We have been helping our customers to register their medical devices since 1992. With our in-depth and latest knowledge, we can help with the registration of your company’s device and setting up processes that meet applicable standards. We have experience with CE marking specification for medical device classes IIa, IIb and class III bio-resorbable. With our global reach, we can support the registration of medical devices in different countries, creating the documents needed. Contact us if you would like to learn more about our quality and regulatory compliance or how we can help you register your device. Get in touch Select the company you would like to contact Italy - Trento Italy - Bologna Italy - Salerno U.S. - Fort Worth, Dayton, Portland, Logan U.S. - Memphis & Cincinnati China - Wuxi What would you like to contact us about? Product information Procurement query Research and development query Regulatory query Media enquiry Other (please write your query in the box below) I would like to be kept up to date with new initiatives, events, new products and new offers through newsletters, with traditional and/or automated contact methods. Privacy * The request for more information is free of charge and not binding, and sending this request constitutes the consent which is optional but necessary to provide you the service. Privacy Lincotek Group S.p.A. will disclose the Users’ Data to the product Strategic Business Units Surface Solution and Medical, since these latter are involved in the manufacturing and distribution of the product Additive. Legal Contact Code of ethics Model of organization, management, and control Newsletter Social WWW.LINCOTEKMEDICAL.COM – owned by Lincotek Rubbiano S.p.A. and used by Lincotek Trento S.p.A. - Via al Dos de la Roda 60, 38057 Pergine Valsugana, Trento (TN) Italy - Phone +39 0461 518901 – Fax +39 0461-518922 - VAT number, Tax Code and Economic Administrative Index No.: : IT 01305350223 - Economic Administrative Index Nr TN - 129060 - Paid-up Capital € 1.806.000,00 PEC: medical.TN@pec.lincotek.it | privacy@lincotek.com | Privacy Policy Web | Privacy Policy Cookie | Rights of Data Subjects | Cookie Settings