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), 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:

• Australia
• Brazil
• Canada
• China
• Europe
• Hong Kong
• India
• Japan
• Malaysia
• Mexico
• Russia
• South Korea
• Taiwan
• Turkey
• United States

Recent changes:
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.
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Free
94
4.7
User ratings
42
Installs
1,000+
Concerns
0
File size
10521 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), 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:

• Australia
• Brazil
• Canada
• China
• Europe
• Hong Kong
• India
• Japan
• Malaysia
• Mexico
• Russia
• South Korea
• Taiwan
• Turkey
• United States

Recent changes:
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.

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