Digital Health – FDA https://www.fda.gov/medicaldevices/digitalhealth/ Dec 7, 2017 – The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to: Reduce inefficiencies,; Improve … Guidances with Digital Health … · Mobile Medical Applications · (Pre-Cert) Program Mobile Medical Applications – FDAContinue reading “FDA and telehealth”
Tag Archives: regulations
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”