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Medistri SA Certified as a Corporate Citizenship

The “Entreprise Citoyenne TM” label is awarded on the basis of prior certification to ISO 9001 (quality management system) and ISO 14001 (environmental management system) standards. A “Entreprise Citoyenne” is one that takes social and environmental considerations into account in its activities and in its relations. It is therefore an organization whose economic, environmental and social goals coexist, while demonstrating that the pursuit of financial profit is not its sole objective.

Packaging

Atmospheric Preconditioning

Atmospheric preconditioning 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.

Medistri SA Certified with ISO 9001

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).

Laboratory

Toxicological Risk Assessment

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

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.

Medistri SA Certified with ISO 14001

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

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.

Sterilisation

EO Sterilisation Technology

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 at Pharmapack 2024

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.

Laboratory

Risk Mitigation

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.