Requirements, regulations, laws, and procedures are necessary for the certification and the quality management of orthopedic medical devices. International standards help in the certification process. This chapter describes the importance of the certification for medical devices that includes the verification and the validation of the mechanical resistance with the aim of obtaining a more and more efficient process demonstrating the reliability of a device toward the confirmation for the CE mark. After describing the main aspect, the chapter shows some practical examples of test for devices based upon the international standards or in case they are missing. The examples also show different methods to perform the necessary tests for analyzing the mechanical performances of an implant. Finally, the chapter focuses on the state of the art and future perspectives.
Biomechanical requirements for certification and quality in medical devices
T. Villa
2022-01-01
Abstract
Requirements, regulations, laws, and procedures are necessary for the certification and the quality management of orthopedic medical devices. International standards help in the certification process. This chapter describes the importance of the certification for medical devices that includes the verification and the validation of the mechanical resistance with the aim of obtaining a more and more efficient process demonstrating the reliability of a device toward the confirmation for the CE mark. After describing the main aspect, the chapter shows some practical examples of test for devices based upon the international standards or in case they are missing. The examples also show different methods to perform the necessary tests for analyzing the mechanical performances of an implant. Finally, the chapter focuses on the state of the art and future perspectives.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
