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ISO 9001 is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system (QMS).

Certain regulatory bodies require a toxicological assessment of extractables and leachables, for certain products, to establish the device’s safety limits of these impurities. ISO 10993-17:2023 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.

Atmospheric Conditioning simulates the effects of different temperature and humidity levels on packages and products. It’s often used to evaluate the performance and durability of packaging materials and products under various environmental conditions.

On the 18th of January 2024, Medistri accreditation application has been accepted. Medistri’s sterilization plant is the first to obtain the ISO 14001 certificate.

Process Validation is a systematic approach used in manufacturing industries, particularly those under stringent regulatory requirements, to ensure that a process consistently produces a product that meets its predetermined specifications and quality attributes.

At Medistri, we’re focused on using our resources to combat climate change. We believe our commitments are both ambitious and necessary. To achieve our objectives, we focus on scalable innovation. Designing and implementing new technologies, mobilising financing structures, and rapidly deploying renewable energy.

Medistri is attending Pharmapack 2024 in Paris, France from January 24 to 25, hosting a booth to cater client meetings, showcase its services and answer all questions.

Risk mitigation through testing in the biocompatibility scenario is a crucial step in the evaluation of medical devices. It involves assessing the biocompatibility of the materials and processes used in the device by taking a risk-based approach to their biological safety evaluations.

Measuring the bond strength of materials is a key factor in determining the reliability and durability of many products. By ensuring the adhesive strength meets the required standards, manufacturers can enhance product quality, improve customer satisfaction, and prevent potential failures or malfunctions.

The Burst Test, as defined by the International Organization for Standardization (ISO) in ISO 2758, is a globally recognized method for assessing the bursting strength of paper. This test, also known as the Mullen Test, is applicable to paper with bursting strengths ranging from 70 kPa to 1,400 kPa.