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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.

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.

Chemical characterization and toxicological risk assessment are central components of the modern biological evaluation of medical devices. Regulators expect manufacturers to demonstrate a clear understanding of the substances present in their device, the potential patient exposure to those substances, and whether such exposures may represent any toxicological concern.

EO remains essential for sterilizing heat- and moisture-sensitive medical devices. But as regulatory expectations tighten, controlling EO in the workplace air and inside packaged product is now a critical part of safety and compliance.

At Medistri, we continuously expand our laboratory services to help manufacturers demonstrate the safety and compliance of their products. Our latest development is a newly validated method for detecting residual Isopropanol (IPA) — a solvent that plays a central role in cleaning and disinfection processes across the healthcare and pharmaceutical industries.

Material identification is a cornerstone of medical device development and quality control. At Medistri, our FTIR (Fourier Transform Infrared) spectroscopy services provide manufacturers with precise, traceable material characterization to support regulatory compliance and patient safety throughout the product lifecycle.

At Medistri, we help healthcare manufacturer ensure that their reusable medical devices are not only safe to use — but also scientifically validated to be cleaned, disinfected, and reprocessed effectively between uses. With the increasing scrutiny from international regulators such as the European Commission and the U.S. FDA, manufacturers must go beyond intuitive instructions and provide robust, validated reprocessing procedures. These procedures must comply with strict standards such as ISO 17664, AAMI ST98, and the ISO 15883 series.

Medical device manufacturers face increasing demands for fast product release, regulatory compliance, and cost control. At Medistri, we offer one of the most competitive and efficient laboratory services in the Swiss market, enabling you to accelerate time-to-market while maintaining the highest quality standards.

At Medistri, we are committed to advancing healthcare through innovation in laboratory and sterilization services. As regulatory standards evolve and global healthcare companies look for faster, more ethical, and more predictive safety assessments, Medistri supports clients in transitioning from traditional animal testing toward validated in vitro and animal-free methods.