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Medical devices are manufactured, assembled, and packaged in environments where contamination, whether particulate, microbiological, or chemical, can directly compromise product safety. Environmental monitoring is the systematic process of measuring and documenting the conditions in these environments, providing manufacturers with the evidence they need to demonstrate that their production areas are under control.

For nearly all medical devices, three biological endpoints form the foundation of a biological safety evaluation under ISO 10993-1: cytotoxicity, irritation, and sensitization. Commonly referred to as the “Big Three,” these endpoints are applicable across virtually all device categories, regardless of the nature or duration of patient contact. At Medistri, manufacturers are supported across these three endpoints through a combination of in-house in vitro testing and coordinated in vivo studies, ensuring that biological safety is demonstrated with scientific rigor and aligned with regulatory expectations.

At Medistri, we are proud to announce that our laboratory has officially been enrolled in the Swiss Good Laboratory Practice (GLP) Compliance Monitoring Programme. The formal decision was issued by the Notification Authority for Chemicals (NAChem) at the Federal Office of Public Health, following a successful inspection process conducted by Swissmedic. Our facility will appear on the official GLP register effective 13 May 2026.

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.