EEHR

New Medical Device Regulation 745/2017 (MDR)

Open Letter on the Implementation and Readiness Status of the New Medical Device Regulation 745/2017 (MDR) Critical review of the new Medical Device Regulation from Medtech Europe. Source: https://www.linkedin.com/feed/update/urn:li:activity:6525149926949781504  
Food and Drug Administration

FDA: Digital Health Policy for Prescription Drug Pricing

New prescription drug-use related software proposed by FDA will help companies and develop an efficient pathway to help increase safety and effectiveness. Read on: www.natlawreview.com/article/significant-fda-digital-health-policy-development-prescription-drug-sponsors
Translated Cochrane evidence 1

Translated Cochrane evidence

Cochrane evidence is currently translated into 14 languages: Croatian, French, German, Japanese, Korean, Malay, Polish, Portuguese, Russian, Simplified Chinese, Spanish, Tamil, Thai, and Traditional Chinese. Each language has its own version of cochrane.org; you can view translations by clicking...
Food and Drug Administration

Software as a Medical Device: FDA Update in May 2018

Until May 31, the U.S. Food and Drug Administration (FDA) has open for comment from the public a proposal for precertification of software as a medical device. Its 17-page proposal is located at https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm605685.pdf....