Rosti Capabilities Markets Sustainability Company Locations News Contact Get in Touch Life science Certified facilities and extensive regulatory requirements needed for consistent performance, together with a strong medical culture and precision manufacturing are all essential in the medical device, diagnostics (IVD) and pharmaceutical markets. With ISO 13485 Medical facilities, ISO 14644-1 certified classrooms, solid quality systems, robust and validated precision manufacturing processes together with a strong medical mentality means you can rely on Rosti to deliver. We are a global, agile and trusted partner to many producers of life science devices, and we offer guidance and support throughout the structured development and manufacturing process. Get in touch Johan Christiansson Global Key Account Manager E-mail: sales@rosti.com Ke Rong Regional Operations Director Packaging and Life Science E-mail: rosti@rosti.com Highest level of standards to meet your requirements on medical production. Our medical manufacturing assembly and testing facilities are equipped with state of the art machine that meet relevant international standards including ISO 13485. The production environment ranges from ‘white room’ to certified clean room class 8 environment (ISO-14644-1) to meet the specific requirements for your products. Our New Product Introduction (NPI) procedure has defined gates with start conditions, scope and goals with overall steering group supervision. It covers both development of new products and transfer of existing products. All tools, equipment and production processes are validated through the Rosti standard validation routine, with IQ, OQ, PQ; or according to specific requirements. We have an experienced and selected network of partners that supports us with tools, auxiliary equipment, end of arm tooling (EOT), resin and other services. Complete project management capabilities Working with Rosti gives you access to complete project management capabilities. We are experienced experts in the manufacturing of technically complex moulded plastic components, as well as contract manufacturing to high levels of precision, but we also support you through every stage of the design, production and delivery processes. As you know, this is an industry with increasing end-user expectations and regulatory demands combined with consistent cost pressures so working with a partner who can foresee the challenges and opportunities can be the difference between success and failure. Rosti delivers precision, quality, performance, agility and care, combined with efficiency to secure that demands and expectations are met at every stage of the process. Case studies Rosti Asia have acquired a contract from a new customer in this post Covid world … Rosti Asia wins new Life Sciences contract Life science Rosti breathes life into a new pharmaceutical product The product in this case s … Breathing device case study Life science At Rosti we are passionate about working with our customers throughout the entir … A medical device for early detection of potential breast cancer Get in touch Please fill out this form and we’ll be in contact with you shortly. Fields marked with an * are required NAME * E-MAIL * COMPANY * ATTACH A FILE SELECT FILES MESSAGE * By sending us your contact information you confirm that you have read and understood our Privacy policy * Discover our capabilities Discover contract manufacturing Discover value added services Discover injection moulding Start Markets Life science Explore Rosti Group Company Markets Sustainability Locations This is Rosti The Rosti way Career News Contact Capabilities Discover contract manufacturing Discover injection moulding Discover quality Discover value added services Contact Rosti Group AB Västra Varvsgatan 19 S211 77 Malmö, Sweden Directions Other locations Phone + 46 (0)40 204 701 General enquiries sales@rosti.com Follow us Rosti Group is a global plastics injection moulding company and contract manufacturer to some of the world’s leading manufacturers in the packaging, consumer appliances, business machines and medical sectors. We are dedicated to providing leading-edge solutions “From concept to reality” to help customers create better components, processes and solutions. © Copyright 2021 – Rosti Group AB. All rights reserved. My cookie settings Cookies policy Privacy policy Terms and Conditions We serve cookies. If you think that’s ok, just click “I Accept”. Read our cookie policy I Accept