QMSR Complaints and Nonconforming Product Our previous post discussed the Suppliers’ control requirements for the Quality Management System Regulation (QMSR). This post will focus on QMSR Complaints and Nonconforming Product requirements. The final QMSR rule can be seen here. QMSR …
Israel Devices Registration Summary This post presents an Israel Devices Registration …
QMSR Suppliers Control Requirements Our previous post discussed the Applicable Regulatory requirements for the Quality Management System Regulation (QMSR). This post will focus on QMSR suppliers’ control requirements. The final QMSR rule can be seen here. Supplier Control Procedure We …
QMSR Applicable Regulatory Requirements Our previous post discussed Design Requirements for the Quality Management System Regulation (QMSR). This post will focus on QMSR Applicable Regulatory Requirements. You can see the final QMSR rule here. Understanding Applicable Requirements In QMSR section …
FDA QMSR Design Documentation In our previous post, we wrote about the requirements for the Medical Device File as per Quality Management System Regulation (QMSR) and discussed what constitutes a Medical Device Family. In this post, we will discuss what …
FDA QMSR and Medical Device File On January 31, 2024, FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System …
Israel Device Declaration Registration – Part II Our previous article on this topic explained that starting in January 2024, medical device manufacturers can register low-risk class I (class I, Is, Im, Ir) and FDA low-risk medical devices in Israel via …
