Digital Health Criteria – FDA https://www.fda.gov/MedicalDevices/DigitalHealth/ucm575766.htm Sep 22, 2017 – Software run on a hardware medical device is a SaMD when not part of the intended use of the hardware medical device. … A picture archiving and communications system consists of cloud–based, web-accessible software that analyzes cardiovascular images acquired from magnetic resonance (MR) … Medical Device Data Systems – FDA https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospital…Continue reading “FDA and cloud-based medical device”
Tag Archives: medical device
Drug and Medical Device Litigations
Medical Device Design Control Implementation Summary List
1. Identify Total Design Control Requirement Review of specific design control requirements, determine their source and identify implementation methods. · Design Control · US – Food Drug and Cosmetics Act & 21 CFR Part 820 · EU – Medical Device Directive (MDD) & EN ISO 13485:2012 · Canada – Canadian Medical Device Regulations (CMDR) &Continue reading “Medical Device Design Control Implementation Summary List”
Training and Training materials, what managers need to know
Skills: We deliver skills training with hands on exercise, one on one skills training with experts, with repetition and encouraging questions and learning. In this format, we build confidence for the learner to use the skills in practical ways, directed to real applications on the manufacturing floor. Knowledge: Instructor led with use of powerpoint, lessContinue reading “Training and Training materials, what managers need to know”