Premaitha Health receives ISO 13485:2003 certification
Achieves significant milestones in preparing for CE-mark and commercial launch
03-Feb-2015 -
Premaitha Health plc announced that it has met two key requirements for obtaining a CE-mark for its IONA® test: ISO 13485:2003 certification and a successful audit of Annex IV of the In Vitro Diagnostic Medical Device Directive (98/79/EC).
The ISO 13485:2003 certification confirms that ...
diagnostic reagents
diagnostics
ISO 13485:2003