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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.

As medical devices and pharmaceutical products move toward market entry, packaging is no longer assessed as a logistical element alone. For products placed on the market as sterile, packaging becomes a regulated system that must be validated to demonstrate that sterility, integrity, and product safety are maintained until the point of use.

As medical devices and pharmaceutical products progress from development to market entry, regulatory compliance becomes a critical success factor. Beyond testing and sterilization execution, manufacturers are increasingly expected to demonstrate a deep understanding of regulatory frameworks, validation principles, and lifecycle control strategies.

In regulated healthcare manufacturing, sterilization is only one part of the product lifecycle. The period that follows, between sterilization and distribution, is equally critical to preserving product integrity, compliance, and supply chain continuity.

As the pharmaceutical industry gathers in Paris for Pharmapack 2026, Medistri joins the event with a clear purpose: connecting innovation, speed, and quality across every stage of healthcare manufacturing.