Helping Abraca BioSystems to obtain ISO 13485 certification

Challenge

ISO 13485 certified QMS to gain access to the MD/IVD industry

As a potential supplier to the medical device / in vitro diagnostics industry, Abraca Biosystems was aiming for the ISO 13482 certification in order to proof reliability also to MD/IVD customers.

Approach

Training, coaching, and support

QbD Group provided introductory training on ISO 13485:2016 and IVDR/MDR and established a coaching program with the Abraca BioSystems Quality and R&D team.

Over the course of 6 months, our experienced ISO 13485 QMS consultant coached the Abraca Biosystems team in writing the necessary procedures and implementing ISO 13485 compliant processes.

During the next 9 months, we further supported them with the preparation for the ISO 13485 certification audit and the definition and implementation of the action plan after the phase 1 and phase 2 audits. The Scilife eQMS was also implemented.

Result

Proud owner of ISO 13485:2016 certification

The goal of this project was to harmonize quality and compliance standards for life sciences to enter these new markets, and also to get their QMS ready for ISO 13485:2016.

This QbD Group coaching project resulted in Abraca BioSystems achieving ISO 13485:2016 certification.