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OstomyCure audit upgrade to Annex II in MDD
Since 2011 OstomyCure has held an ISO13485 quality system certificate with technical files in accordance with Annex V/III of the European Medical Device Directive 93/42/EEC (MDD). We are committed to constant improvements and increasing sophistication, and as evidence, our certification was upgraded to a higher level after the latest audit by our Notified Body; now it also meets the requirements of Annex II, Full Quality System, of the MDD.
OstomyCure today announced the appointment of Cindy Wong, M.D. as Chief Medical Officer (CMO).
OstomyCure AS has been published in The Ileostomy & Internal Pouch Support Groups latest issue of the IA Journal.
OstomyCure AS engages Morten Gunvad, currently founder and Head of GP Consulting GmbH, as Chief Commercial Officer of the TIES® System.
The TIES® Implant and Lid will be represented at Almedalsveckan, an annual political event taking place in Visby, Sweden.
Aimed to dramatically improve the patient’s quality of life, the TIES® System, a new concept in continent ileostomy receives CE marking.
Today, OstomyCure is very pleased to announce that the TIES® System has received approval for CE marking from our Notified Body.
Comprising an implantable medical device, the TIES® System requires approval from a Notified Body in order to obtain CE marking and to be marketed in Europe.
The ongoing TIES® clinical study is moving forward and is now fully enrolled with the planned number of patients.
OstomyCure is pleased to announce the participation of the Ahus University Hospital in Norway in the ongoing TIES® clinical study.