This blog has highlighted the blindness of professionals and the hypocrisy of regulators in imposing the expensive treatment of ISO accreditation on healthcare without evidence of any efficacy, effectiveness or value.
An analysis published by the BMJ makes interesting reading regarding the lack of trials before medical devices may be used in the EU. The same trans-national government imposes untested ISO accreditation on its Official Control Laboratories and others.
As the EU debates new legislation to regulate medical devices, Philipp Storz-Pfennig, Mechtild Schmedders, and Matthias Dettloff provide examples from Germany to show why the current proposals do not go far enough and call for further assessment after market approval…
For what reason should accreditation bodies be exempted from these proposals?