Medical Device Regulatory
Free App
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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
• Australia
• Brazil
• Canada
• China
• Europe
• Hong Kong
• India
• Japan
• Malaysia
• Mexico
• Russia
• South Korea
• Taiwan
• Turkey
• United States
All Application Badges
Free
downl.
downl.
Android
2.3.3+
2.3.3+
Bug
buster
buster
Android app
App History & Updates
What's Changed
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.
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.
Version update Medical Device Regulatory was updated to version 1.02
More downloads Medical Device Regulatory reached 5 000 - 10 000 downloads
More downloads Medical Device Regulatory reached 1 000 - 5 000 downloads
Version update Medical Device Regulatory was updated to version 1.01
What are users saying about Medical Device Regulatory
M
by M####:
by M####:
Good app
T
by T####:
by T####:
Useful, clear and easy to use.
Z
by Z####:
by Z####:
Love the ability to skip directly to the different sections of the European MDD and 21 CFR 820 and other subparts.
Z
by Z####:
by Z####:
Great app and easy to use
Z
by Z####:
by Z####:
This aps. Big help for me to know overseas medical device regulation
Z
by Z####:
by Z####:
It would be nive to have also the preamble to 21CFR820
by O####:
Gd app