Sterilisation for Medical Devices
The combined resources & complete integration of expertise from our laboratory, sterilisation & quality team allow you to fully integrate the development of your products within your existing operational workflow.
Transport Simulation — ISTA 2A, Part 3 - Vibration Testing
The purpose is to analyse the properties of both the packaging shipping unit as well as the final product, and evaluate if the sterile barrier integrity sealing is not damaged when faced with random vibration inputs.
Medistri's official Instagram page
Three months after the launch of instagram page, we’re proud to see the growth of our community and our industry-peers on the social network.
Cytotoxicity Testing — ISO 10993–5
Cytotoxicity testing is used to determine the toxicity of medical devices and materials. Cytotoxicity testing evaluates whether a material can affect living cells. Medical Device Manufacturers are required to show that their devices are not cytotoxic.
Biocompatibility Testing - ISO 10993
Biocompatibility is defined as “The ability of a device material to perform with an appropriate host response in a specific situation”.
Transport Simulation — ISTA 2A, Part 2 - Compression Testing
Compression risks are about the most frequent concerns that products and containers experience during the logistics chain.
Volatile Organic Compounds (VOCs) Analysis by GC/MS
ISO 10993-18 focus on chemical characterisation of medical device material within a risk management process. Part of this process is the identification, quantification of extractables and leachable compounds using gas chromatography/mass spectrometry (GC/MS) technology.
GC/MS Analysis
GC/MS Analysis (also called Gas Chromatography/ Mass Spectrometry) is an analytical process that utilises the capabilities of Mass Spectrometry and Gas Chromatography in order to determine the chemical compounds within a sample.
Medistri’s EO Sterilisation Validation Flow
An Ethylene Oxide (EO) Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed.
Episode 3: Behind The Growth
In this episode of Behind the Growth, Our Site Technical Director, Mr. Sylvain Vasseur, joint us to discuss his work, how long has he’s been working at Medistri and what are the things that he likes about working within a growing company.
