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For many years, healthcare quality has been enhanced by medical devices. These devices are made with strict safety and risk evaluation processes to ensure they work as intended and safeguard patients’ health. To maintain high quality control standards, manufacturers have to check their medical devices regularly. One of the methods to assess the safety of a device is to look for any harmful microorganisms that might infect the device. This is done by using microbiological tests.

Sterilization is a critical process in the healthcare industry which is used to ensure that medical devices and products are free from harmful microorganisms. One of the methods used to achieve this is irradiation, which involves exposing products to ionizing radiation to destroy or inactivate microorganisms. To ensure that the sterilization process is effective, it is important to accurately determine the dose of radiation required.

Plastics testing is a process that involves evaluating the compatibility, stability and integrity of plastic materials used for packaging or manufacturing medical devices that undergo sterilisation. Plastics testing can also include the analysis and screening of phthalates, which are a category of chemical compounds that are used as a form of additive in plastics.

On the 30 of June, Medistri re-accreditation application has been accepted. Since its foundation in 2006, Medistri has continued to grow into one of the leading providers of contract sterilization & laboratory services for healthcare companies.

ASTM is one of the world's leading international quality organisations. The ASTM guidelines are an agreement between consumers, manufacturers, government agencies and scientists from over 140 countries on the implementation of packaging quality and testing requirements.

Heavy metal elemental analysis is the process of measuring the concentration and composition of metals in biological samples. Heavy metals can be toxic and essential for living organisms, depending on their dose and bioavailability. Therefore, it is important to monitor their levels in the environment.

The Toxicological Studies provide a consistent definition of the circumstances under which it is necessary to undertake studies on new drugs and/or devices. The recommendations take into account the known risk factors as well as the intended indications and duration of exposure. Following standards such as ISO 10993 also helps to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. Additionally, following standards can increase sensitivity and reduce the number of animals required for overall safety evaluations.

Reprocessing and cleaning validation are essential processes in the medical device industry - it’s critical to ensure the safety and effectiveness of medical devices. These processes help to prevent the transmission of infections and ensure that devices function as intended. Both reprocessing and cleaning validation are subject to strict regulations to ensure that they are carried out correctly and effectively.

The validation of steam sterilization on products includes both physical and microbiological qualification processes. These processes are performed to ensure that the sterilization process is effective in deactivating microorganisms and providing a sterile product for later use.

Sterilisation is an important method that manufacturers widely use to keep medical devices safe for patient use. It is a considered a ‘cold’ sterilization technique and offers high compatibility with most materials used in the manufacturing & packaging of medical devices, such as plastics, polymers, metals and glass. For many medical devices, EO sterilisation may be the only method that effectively sterilizes without damaging the device during the sterilisation process.