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Shelf-Life Studies

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.

NEW

Medistri Joins Swiss Medtech: Strengthening Our Role in the Swiss MedTech Sector

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.

Manufacturing Services

Product Assembly Services

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.

Sterilisation

Routine Sterilization

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.

Packaging

Packaging Validation

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.

Regulatory Consulting Services

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.

Post-Sterilization Storage Services

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.

Visit Medistri at Pharmapack 2026

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.

Sterilization Validation

As medical devices and pharmaceutical products progress toward commercialization, regulatory compliance and documented evidence become prerequisites for market access.

Manufacturing Services

Cleaning & Reprocessing

In regulated manufacturing environments, cleaning and reprocessing play a critical role in ensuring that materials and products can safely and consistently progress through downstream operations. These activities directly support product quality, process reliability, and regulatory compliance across a wide range of healthcare manufacturing services.