---
title: "Helping Abraca BioSystems to obtain ISO 13485 certification"
description: "QbD Group helped Abraca Biosystem gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification."
url: https://qbdgroup.com/en/case-studies/helping-abraca-biosystems-to-obtain-iso-13485-certification
type: "Case study"
language: en
published: 2022-06-16
publisher: "QbD Group"
citation: "QbD Group, \"Helping Abraca BioSystems to obtain ISO 13485 certification\", https://qbdgroup.com/en/case-studies/helping-abraca-biosystems-to-obtain-iso-13485-certification"
---
# Helping Abraca BioSystems to obtain ISO 13485 certification
> QbD Group helped Abraca Biosystem gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

[Abraca BioSystems](https://abracabiosystems.com/) serves the Life Sciences industry by developing innovative **separation** and **purification technologies** based on microporous **silica-polymer membranes**.

Their products have practical applications in research labs, pharmaceutical & biotech manufacturing, and diagnostics.

## 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.
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Source: https://qbdgroup.com/en/case-studies/helping-abraca-biosystems-to-obtain-iso-13485-certification — © QbD Group. Quote freely with attribution and a link back.