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.
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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.