Bioelectronics Corp (BIEL)

[seven-up]

10.Standards: (Read my post 110055 to you simple)
ISO 13485:2003 Quality System Standard
ISO 13485:2012 Medical Devices: Quality Management Systems
ISO 14155 Clinical investigation of medical devices for human
subjects.
ISO 14971: 2012 Risk Management
ISO 10993-6:2009 Part 6 Evaluations of Medical Devices
SOR/ 98-282 G D 207 & GD 210 Canadian MDR Quality Systems
93/42/EEC 2012/47/EC Council Directive
BS EN ISO 15223-1:2012 Labeling of Medical Devices
EN 1041:2008 Information Supplied with Medical Devices
EN 60601-1-2:2012 Electromagnetic Compatibility Requirements &
Tests
EN 60601-1-11: 2010 Home Health Care Environment
EN 60601 -1: 2006 Medical Electrical Equipment Requirements and
Tests
EN 60601-2-3: 2012 Short-Wave Therapy Equipment
EN 60601-2-10: 2001 Safety of Nerve and Muscle Stimulators
MEDDEV 2.7.1 Rev. 3 Clinical Evaluation
MEDDEV 2.12-1 Rev.8 Vigilance System in Europe
MEDDEV 2.12/2 rev. 2 Post Market Clinical Follow-Up Studies
MEDDEV 12.2-2 Rev. 2 Post Market Surveillance

Yep that is why Biel has cleared the FDA for OTC, they have met the requirements of the FDA LOL