Omda AS

Overarching responsibility for ensuring that Omda maintains a quality management system that fully complies with the requirements of ISO 13485:2016 and Regulation (EU) 2017/745 (MDR).

Responsible for ensuring that all products defined as medical devices within business unit Maternity & Fertility (MAFE) are developed in accordance with Omda’s Quality Management System (QMS), thereby ensuring that all formal requirements are satisfied in accordance with ISO 13485:2016 and Regulation (EU) 2017/745 (MDR). This applies for the following product(s): Omda Partus

Responsible for ensuring that all products defined as medical devices within business unit Medical Oncology (MEON) are developed in accordance with Omda’s Quality Management System (QMS), thereby ensuring that all formal requirements are satisfied in accordance with ISO 13485:2016 and Regulation (EU) 2017/745 (MDR). This applies for the following product(s): Omda Cytodose

Responsible for ensuring that all products defined as medical devices within business unit Medical Oncology (MEON) are developed in accordance with Omda’s Quality Management System (QMS), thereby ensuring that all formal requirements are satisfied in accordance with ISO 13485:2016 and Regulation (EU) 2017/745 (MDR). This applies for the following product(s): Omda Cytodose

Responsible for ensuring that all products defined as medical devices within business unit Medical Imaging (MDIM) are developed in accordance with Omda’s Quality Management System (QMS), thereby ensuring that all formal requirements are satisfied in accordance with ISO 13485:2016 and Regulation (EU) 2017/745 (MDR). This applies for the following product(s): Omda Picsara, Omda ECG diagnostic tool