The first review of DGM's capability as CAB was finished on 3 February 2000 with a recommendation from MDA (Medical Device Agency) to the Danish Ministry of Health that DGM has fulfilled the basic requirements as defined in the MRA (Mutual Recognition Agreement) for a Conformity Assessment Body. The Danish Ministry of Health will now submit its recommendation to FDA and the EU Commission.
To be nominated as a CAB the candidate must train its reviewers and auditors to qualify for reviewing of 510(k)s and for inspection of quality systems according to 21CFR§820:1996 (United States Food and Drug Administration Quality System Regulation).
Since December 1999 DGM has participated in 3 qualifying inspections with the FDA in Denmark and 4 additional inspections are planned.
