Know everything about our services

As the medical industry advances, devices are becoming more compact & connected. Many of today’s innovations include integrated electronics - microchips, sensors, batteries, or embedded software, that allow for monitoring, adjustment, or data transmission. These features improve patient outcomes, but they also create new challenges when it comes to sterilisation.

Medical Device and Pharmaceutical companies must ensure their products are safe for use and compliant with international regulations. Extractables and Leachables (E&L) testing plays a key role in this effort, as outlined in standards such as ISO 10993 and the United States Pharmacopeia (USP). At Medistri, we provide comprehensive E&L analyses to support product development, regulatory submissions, and patient safety.

Sterilization is a critical process for ensuring the safety and efficacy of pharmaceutical products, particularly in packaging and injectable solutions. Medistri offers contract sterilisation services that meet rigorous pharmaceutical manufacturing standards. 

We are pleased to announce that Medistri has expanded its scope of services under the Swiss Accreditation Service (SAS). Since its founding in 2006, Medistri has grown into a leading provider of contract sterilization and laboratory services for healthcare companies, becoming a trusted partner for businesses in the pharmaceutical, medical device, and biotechnology sectors.

At Medistri, we recognize the critical importance of cytotoxicity testing in the development and approval of medical devices. These tests are not merely regulatory checkboxes but are fundamental to ensure that materials used in medical devices are biocompatible and safe for direct human contact. This blog delves into the sophisticated methodologies we employ and the standards we adhere to, ensuring the highest level of safety and compliance.

Steam sterilization is an efficient and reliable method for decontaminating medical devices and pharmaceuticals. By exposing products to saturated steam at temperatures between 121°C and 134°C, this process ensures thorough microbial eradication while preserving product integrity. Carefully controlled temperature, pressure, and humidity provide an optimal environment for steam to effectively sterilize every surface. The result is a trusted solution that maintains the functionality of your products while ensuring their safety.

At Medistri, we specialize in the precision-driven assembly, packaging, and sterilization of medical devices or pharmaceutials, catering to both emerging startups and established companies. Our process is designed to support the unique needs of each client, from prototype development to routine large-scale production.

At Medistri, we’re always exploring new ways to make your logistics planning smoother and more efficient. That’s why we’re excited to introduce the Logistics Heatmap Tool - an innovative solution designed to provide you with valuable insights into your supply chain. With this tool, you can make more informed decisions and optimize your logistics strategy, all by simply looking at historical data that is visualized in an easy-to-understand format.

The design of a medical device’s packaging plays a critical role in ensuring the product’s success and safety. It should be developed during the early stages of the device’s creation to avoid costly challenges later. Packaging is not just a protective layer; it serves as a sterile barrier that safeguards the medical device from manufacturing to final use.

Medistri is proud to announce the opening of our new facility in Székesfehérvár, Hungary, marking a significant milestone in our mission to enhance global healthcare solutions.