OUALITY MANAGEMENT

Quality Certifications & Compliance

SensID operates under a certified quality management system and adheres to internationally recognized standards, including:

– DIN EN ISO 13485:2016
– Directive 98/79/EC

These certifications reflect our commitment to quality, traceability, and product reliability.

Our commitment to quality has guided SensID’s growth from product development through regulatory certification and accreditation.

2018

Development of our first products begins

2019

Implementation of an ISO 13485:2016-certified Quality Management System

2020

Successful initial certification to ISO 13485:2016

2022

Registration and launch of our first IVD product, initiation of IVDR transition activities, and FDA establishment registration

2023

Successful recertification to ISO 13485:2016