Medical Device Biological Evaluation Plan
At Medistri, we aim to address these issues by using a scientifically sound risk-based approach to determine the most appropriate testing methods for each device. That’s why we follow the guidelines outlined in ISO 10993–1:2018 and the FDA’s guidance document on the use of this standard, which require a structured biological evaluation plan as part of a risk management process in accordance with ISO 14971
Total Organic Carbon (TOC)
Organic contaminants in medical devices can cause adverse reactions in patients, reduce the effectiveness of the device, or cause the device to malfunction. TOC analysis can identify and quantify these contaminants, allowing manufacturers to ensure that their medical devices meet regulatory requirements and industry standards.
Elemental and Trace Metal Analysis for Pharmaceuticals
For pharmaceutical manufacturers, Elemental and Trace Metal Analysis is an important step towards development, quality control, and release. Medistri’s in-house GMP laboratory works with it customers to design pharmaceutical organic and inorganic elemental analysis.
Medistri to Welcome it's Fifth Sterilization Line
Medistri, a leading provider of contract sterilization & laboratory services for healthcare companies, is excited to announce the arrival of its fifth sterilization line this week. The new chamber will be used primarily for the sterilization of pharmaceutical & medical devices coming from multiple countries. It will be fully operational and ready to use by the beginning of 2023.
BPA Testing Services
Bisphenol A (BPA) is a compound used to make certain polycarbonate materials and epoxy resins. Medistri can perform BPA trace level detection analysis and screening of products and materials.
Medical Device Shelf-Life Studies
Medistri perform accelerated aging while performing real-time aging tests to generate shelf-life data for medical device manufacturers. This data is used in the product’s design-history files, technical dossiers and 510(k) submissions.
Accelerated Aging Testing for Medical Devices
Accelerated Aging is a standard practice in several different industries. Medistri specialises in conducting Accelerated Aging tests on medical devices.
Medistri at Pharmapack 2023 in Paris
Medistri is attending Pharmapack 2023 in Paris, France from February 1 to 2, hosting a booth to cater client meetings, showcase its services and answer all questions.
Medistri will be featuring its commitment to innovative speed, uncompromising quality, and tailored sustainable solutions.
Sterility Testing for Medical Devices
Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and is performed in a cleanroom environment.
Introduction to Steam Sterilisation
Steam sterilisation works by placing products in a steam autoclave and exposing the products to pressurised steam at high temperatures in order to destroy viable microorganisms. This allows for the creation of saturated steam which will immediately induce condensation on the surface of the product to sterilise.
