The guide “Clinical evaluation – Summary of safety and clinical performance (SSCP) – Regulation (EU) 2017/745” covers devices with a medical purpose and products without a medical purpose without a medical purpose listed in Annex XVI of Regulation (EU) 2017/745. ...
In the absence of EUDAMED, manufacturers of Class III and Implantable/Class D devices will need to submit the PSUR to the Notified Body through the BSI Electronic Client Portal. This should be performed annually for Class III, IIb and Class D devices and every other year for Class IIa device...
Security and Risk Management (SRM)is the first book in my “The Effective CISSP (TEC)” series. I wrote this book as a supplement or complement but not a replacement to the well-known study guides, e.g., the Sybex Official Study Guide (OSG) or McGraw-Hill All-In-One (AIO). This ...