Tag Archives: ISO 13485

SGS Belgium NV Receives Designation as Notified Body under EU IVDR to Support In Vitro Diagnostic Device Compliance

(IN BRIEF) SGS Belgium NV has been officially designated by the European Commission and Belgian Competent Authority as a Notified Body (NB) under the In Vitro Diagnostic Medical Device Regulation (IVDR), EU 2017/746. This milestone enhances SGS’s ability to support … Read the full press release

SGS Belgium Designated as EU Notified Body for In Vitro Diagnostic Medical Devices

(IN BRIEF) SGS Belgium NV has been designated as a Notified Body under the EU’s In Vitro Diagnostic Medical Device Regulation (IVDR), expanding Europe’s limited capacity for regulatory assessments. Approved by the European Commission and Belgian authorities, the Antwerp-based facility … Read the full press release

Origami and citoQualis Team up for Startups

Origami and citoQualis Team up for Medical Device Startups

(PRESS RELEASE) KFAR SABA, Israel, 9-Nov-2021 — /EuropaWire/ — Origami, a leading provider of no-code business process automation software for Medical Device and other industries, and citoQualis, a regulatory and business advisory leader for EU Medical Device companies, are announcing … Read the full press release