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YOUR NAME,OUR REPUTATION DELIVERING CLINICAL UTILITY


Our business model is designed to adapt to our client’s specific manufacturing and material development needs. We off er the resources, knowledge, and experience necessary to provide rapid research and development and a smooth transition into commercial production.


To find out more about what we can do for you:


www.tescoassociates.com


QUALITY


Our team puts the quality and integrity of the device first in every stage of development. TESco has a stringent and robust quality management system, certified to ISO 13485:2016 and registered with FDA 1226183.


EXPERIENCE


• Injection Molding & Extrusion • Material Selection and Compounding • FDA Submission Assistance • Packaging and Sterilization Support • Assembly


MATERIAL INNOVATION


We have a full portfolio of material formulations with FDA master files in place. Our knowledge of bioabsorbable/biodurable polymers and co-polymers covers a wide range of molecular weights.


CLEAN ROOMS


• 12 ISO Class 7 Cleanroom Suites that are ISO Class 6 capable


• Independent suite design to facilitate proper line clearance


• The multiple phases of production, prototyping and material preparation can be completed simultaneously


• Stringent BioBurden control


• Controlled anteroom to allow the transferring of product from one process stage to another without leaving the cleanroom environment


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