After I posted the news of the Health Navigator been certified as a medical device http://www.informationenergymedicine-academy.com/category/news/health-navigator-has-been-certified-as-medical-device/ I got several requests to send one or all of the 22 effectiveness studies that were the basis of its certification.
Here is one of the sad truth, that I had to learn in almost 2 year process towards certification :
The Studies that are the basis of a 93/42/EEC are locked up in the offices of the notified body (another one of these bureaucrat invention words that mean nothing as long as not somebody explains you what it means … here it is the certifying agency) which means that nobody can learn what is behind the effectiveness stamp that this agency provides
We have to know that certifying agencies were started when some of the first steam engine boilers exploded because of manufacturing defects, since then they have served to make machines more save …. but as with any institution that is missing DLE have turned into its opposite, a money making, progress delaying machinery of a lot of Bureau-cracy
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Certification gives doctors the illusion they can treat or diagnose while keeping responsibility and involvement of their own shoulders.
There is no purpose in my eyes to keep the studies locked-up other than to create more money for the certifiers and the experts that always have to create and charge for new studies that re-confirm the same facts.
But please be aware certification does not certify the legality of using it in a particular function as such. A Medical Device is not certified/ approved for a certain function but ONLY for use on specific diseases for which it has proven effectiveness. These indications have to be made public and be part of the manual, if not you have a right to return the system. It is nonsense for example to speak of a MEDICALLY CERTIFIED BIOFEEDBACK DEVICE. If you use such as device for any disease outside the one or two that it usually has proven effectiveness for, you are making yourself liable. The Health Navigator has proven effectiveness for the following 3 very wide indications :
1. Pain Therapy
2. Wound healing
3. Depression
for more details please see :
