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At Medistri, we understand that every laboratory result is only as reliable as the method behind it. Analytical method validation is the process by which a laboratory demonstrates, through documented and objective evidence, that a method is fit for its intended purpose.

Medistri is expanding its sterilization infrastructure with the addition of a second EO sterilization chamber at its facility in Székesfehérvár, Hungary. This expansion increases available capacity and strengthens supply chain reliability for healthcare manufacturers operating across development and industrial production phases.

Healthcare products are rarely delivered to hospitals as isolated components. Instead, they are increasingly provided as pre-configured procedural kits containing multiple sterile or non-sterile components required for a specific clinical intervention. These kits may include implants, single-use devices, pharmaceuticals, accessories, and protective materials assembled into a single validated packaging system.

Sterilization processes are often associated with standardized cycle recipes designed to treat a broad range of healthcare products. In practice, however, many medical devices, pharmaceutical components, and packaging systems require sterilization conditions that cannot be reliably addressed using predefined cycle parameters.

Medical devices and pharmaceutical products often travel long and complex distribution routes before reaching the point of use. During transportation and storage, packaging systems are exposed to mechanical stresses, environmental fluctuations, and handling events that may challenge their protective performance.

At Medistri, we have been working through the 2025 revision of ISO 10993-1 with clients since it was published in November. The question we hear most often is some version of the same thing: do we need to redo our chemical characterization study and toxicological risk assessment? The honest answer is that it depends — and more often than manufacturers expect, the answer is no, or not yet. What usually needs to change is how existing work is documented and positioned within the biological evaluation file. This article sets out where the real differences lie.

Medical devices placed on the market with an expiration date must demonstrate, through documented evidence, that their safety, performance, and integrity are maintained throughout their intended shelf life. Shelf-life studies are a critical component of a manufacturer's technical documentation and regulatory submissions, under both EU MDR and FDA frameworks, and serve as the evidentiary foundation for the expiration dates printed on every device label.

Medistri is pleased to announce its official membership in Swiss Medtech, the leading association representing the Swiss MedTech industry. This membership marks an important step in strengthening Medistri’s active participation within the Swiss healthcare and MedTech ecosystem.

Before a medical device or pharmaceutical product can enter pre-clinical evaluation, it must first exist as a consistent and reliable physical product. At this decisive moment in development, product assembly transforms design intent into tangible reality shaping how a product will be tested, refined, validated, and ultimately industrialized.

As medical devices and pharmaceutical products transition into the industrialization phase, manufacturing activities evolve from development-driven execution to stable, repeatable production under controlled conditions.