Useful Links

 

Australian Government Department of Health - Therapeutic Goods Administration.......

China Food & Drug Administration..................................................................................

European Commission......................................................................................................

European Harmonised Standard.......................................................................................

EU Medical Device Standard............................................................................................

EU IVD Standard..............................................................................................................

EU Implantable Standard.................................................................................................

European Union Law.........................................................................................................

 

Health Sciences Authority................................................................................................

International Medical Device Regulators Forum...............................................................

Medical Devices Information............................................................................................

Medical Device Resource Library......................................................................................

Pharmaceuticals & Medical Devices Agency.....................................................................

Saudi Food & Drug Authority...........................................................................................

U.S. Food & Drug Administration.....................................................................................

ORA innovations boasts over 30 years of combined experience in Quality Management Systems, Compliance, Project Engineering, Product Development, Auditing, Training, New Product Introduction, Documentation and Manufacturing for diverse industries from Electronic Equipment, to Medical Devices and Pharmaceuticals.

With a wealth of experience in Implementing, Auditing and Managing Quality Management Systems ORA innovations has led a number of Medical Devices Companies to achieve their certification to ISO13485, CE Mark their products and others to ISO 9001.

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