Medical Device Regulatory

Medical Device Regulatory


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) and the IVD Directive (98/79/EC). This app includes regulatory information covering 90% of the global medical device market including:

• Australia
• Brazil
• Canada
• China
• Europe
• India
• Japan
• Mexico
• Russia
• South Korea
• United States

Recent changes:
Update 14 October 2013 - now includes EU IVD Directive (97/79/EC), 10 additional US regulations, updated versions of the Regulatory process charts. Regulatory Process charts now include Argentina and Saudi Arabia, and feature Timeline to Medical Device Approval for 19 countries.
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Free
93
4.7
User ratings
29
Installs
1,000+
Concerns
0
File size
19999 kb
Screenshots
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About Medical Device Regulatory
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) and the IVD Directive (98/79/EC). This app includes regulatory information covering 90% of the global medical device market including:

• Australia
• Brazil
• Canada
• China
• Europe
• India
• Japan
• Mexico
• Russia
• South Korea
• United States

Recent changes:
Update 14 October 2013 - now includes EU IVD Directive (97/79/EC), 10 additional US regulations, updated versions of the Regulatory process charts. Regulatory Process charts now include Argentina and Saudi Arabia, and feature Timeline to Medical Device Approval for 19 countries.

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Android Market Comments
A Google User
Feb 8, 2014
Nice
A Google User
Jan 9, 2014
Great app and easy to use
A Google User
Oct 14, 2013
Great interactive versions of MDD and QSR Love the ability to skip directly to the different sections of the European MDD and 21 CFR 820 and other subparts.
A Google User
Oct 14, 2013
Very good app Useful, clear and easy to use.
A Google User
Jun 26, 2013
Good aps This aps. Big help for me to know overseas medical device regulation