Biological Safety Evaluation

We perform tests, characterization and evaluation of biological safety of medical devices and related manufacturing processes:

• Using smart strategies instead of head down approach test programs with high associated costs 

• In relation to specific processes and product, considering all available information relating to materials, products and  similar processes

• In accordance with the directives, regulation and guidelines

• Defining methods that based on our experience extend far beyond the simple interpretation of the guidelines and the specific regulations

• With the final goal to ensure conformity of the product and patient safety

Our main areas of expertise are:

• Qualification of the biocompatibility of the devices / materials

• Qualification of procedures for cleaning, packaging, and sterilization

• Qualification and monitoring of production and packaging systems

• Validation of reusability

In particular:

• Selection of the approach of testing in a product-based or and / or process-based

• biological and chemical characterization of the profile of solubility, organic and inorganic leachable and extractable carcinogenic substances / impurities of materials (cytotoxicity tests, chemical analysis GC-MS, GC-FID, ICP-MS, et. Al.) (ISO 10993-1, -3 - 5, -7, -10, -11, -12, -13, -14, -18)

• Stability to corrosion of metallic materials, electrochemical test, immersion (ISO 10993-1, -15)

• hemocompatibility (ISO 10993-1, -4)

• biostability of the installations (ISO 10993-1, -6, -13, -15, -18)

• Overall assessment of the biocompatibility of toxicological risk management (ISO 10993-1, -17), in consideration of the characteristics and toxicological profile of the materials used, the substances released, literature data and experience with the application

• additional tests of biocompatibility after storage, reprocessing

We carry out, in accordance with ISO 10993, the following tests to ensure the biological safety and biocompatibility of the analyzed product:

For any information relating to testing and / or monitoring of the biological safety of a medical device or its production process please do not hesitate to contact us!

Copyright 2015 P.IVA 03983530407 - - Via Riva Del Garda 7 - Riccione - (RN) - Tel. 0541 1797426 - Fax. 0541 1797423Biological Safety Evaluation - TS Quality & Engineering.
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