Polymer Bioresorbable polymers Quality

Quality management and safety of bioresorbable polymers for biomedical applications... 

To address the quality management and safety related to bioresorbable polymers, we begin by listing the main classes of these polymers [1] and then provide an overview of their principal uses ... 

The industrial production of a medical device is a complex activity that requires fine-tuning of the technical parameters to satisfy the requirements of quality, reproducibility, and reliability that are necessary to meet customer needs and regulatory directives. For bioresorbable polymers, this activity is even more complex, due mainly to the following factors (1) aptitude to degradation of resorbable polymers, (2) high costs of production, and (3) scarcity of suppliers. 

The choice of the right suppliers for raw materials is critical because validation of a bioresorbable polymer includes the characteristics of all the suppliers involved in the production process, ie, their quality systems and certifications. An unreliable supplier represents a possible source of issues when producing a device under regulatory approval. For example, a supplier could fail obliging the company to begin a validation process for the new supplier, the quality of the raw material could be erratic, or the supply of a determined material could be discontinued [20]. Moreover, in the past years the number of suppliers of bioresorbable materials did not increase as expected,... 

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