Replies to post #110070 on Bioelectronics Corp (BIEL)

[HORUS]

Do more DD.

[uksausage]

And you highlight boiler plate text that is in all FDA clearances.

is there any evidence that BIEL is NOT complying with the act, remember they have been selling an FDA cleared device for many years ahead of the OTC clearance for Actipatch.

would they have cleared Actipatch if they knew they were not complying?

[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