A valuable reference tool for medical device Regulatory Affairs (RA) and Quality Assurance (QA) professionals. Quick access to global medical device regulations, daily medical device regulatory updates, quick access to regulatory resources (videos, downloadable regulations, and more) for 24 countries. Also the full text of the US FDA QSR (Quality System Regulation, 21 CFR Part 820) and 10 other US regulations, plus full text of the European Medical Devices Directive (MDD 93/42/EEC), the IVD Directive (98/79/EC), and Directive 2007/47/EC. This app includes regulatory information covering 90% of the global medical device market including:
• Hong Kong
• South Korea
• United States
Update 27 August 2015 - now includes EU DIRECTIVE 2007/47/EC, updated USA FDA QSR (21 CFR Part 820) and other updated FDA regulations, updated versions of the Regulatory process charts. Regulatory Process charts now include Colombia, Malaysia, Taiwan and Turkey, and feature Timeline to Medical Device Approval for 20 countries.