myBioma: The road to success with quality management and customer focus

myBioma the world's first health tech company in the field of microbiome analysis certified according to ISO 9001: 2015 and ISO 13485: 2016!

The Austrian company myBioma is the first company in the field of microbiome analysis to achieve certification in accordance with ISO 9001: 2015 and ISO 13485: 2016. Thereby, myBioma guarantees the availability of all products and services with the highest quality standards. This marks a milestone for the entire microbiome sector.

"We chose ISO certification because the quality and scientific foundation of our bioinformatics analyses are our top priority. When dealing with people and their health, there should be no discussion about the quality of the products and the validity of the diagnoses. As a young and emerging company in a complex field, such as microbiome analysis, we are very pleased to be the first in the world to meet these international standards.” says Dr. Barbara Sladek MBA, co-founder of myBioma.

Why ISO 13485 and  ISO 9001?

The combination of both ISO certificates was of great importance to the founders Dr. Barbara Sladek and Dr. Nikolaus Gasche. ISO 13485 regulates the requirements for quality management systems for medical device manufacturers, thus ensuring high standards in the development, manufacture and marketing of medical devices. Additionally, the ISO 9001 ensures continuous improvements to the products themselves and the enhancement of customer satisfaction.

The renowned certification body MDC (medical device certification GmbH) carried out a two-stage audit in February 2020. In the first stage, it was verified that the company had correctly implemented all of the processes required by the standards. In the course of the second stage, the details of the individual processes (such as software development and ensuring data security) and the fulfillment of specific tasks (such as communication of customer demands) were assessed. The scope of the complete certification thus includes the development, production, design and sale of the developed analysis platform as well as the stool sample collection kits. During the development of the quality management system, particular attention was paid to the security of personal data and the development cycles of the myBioma analysis platform. 

Big plans for the future

The company is already involved in clinical studies with its product in order to evaluate the relevance and usefulness of the gut microbiome in the field of medical therapies. In the future, the aim is for diagnoses and specific therapy plans to be based on the individual intestinal microbiome of patients.

Using standardized interfaces, laboratories and hospitals are offered a simple and inexpensive way to integrate the analysis platform developed by myBioma into their own applications.

“We are concentrating on tapping into the diverse, diagnostic potential of the gut microbiome. Our vision is to optimize existing medical treatments based on our analysis of intestinal bacteria. We aim to achieve this by application of the latest technologies, such as next-generation sequencing of bacterial genes,” says Dr. Nikolaus Gasche, co-founder of myBioma.

What is the gut microbiome?

Over 1,000 different bacterial strains and over 30 trillion microorganisms can be found in the gut of every human being. The term “microbiome” includes all bacteria, fungi, viruses, archaeabacteria and their genetic information. In order for us to feel fit and healthy, there must be a balanced collaboration between the intestine and the bacteria, sufferings may occur if it is unbalanced. For some time now, the medical field has recognized the gut microbiome as a separate organ.

About myBioma

myBioma is Austria's leading bioinformatics company in the field of intestinal microbiome analysis. Using the latest technology (for example 16S gene sequencing) and in scientific cooperation with the Medical University of Vienna, the company analyses the gut microbiome. The core competence of myBioma lies in the in-depth analysis of the genetic strains of intestinal bacteria and the subsequent interpretation of the results. The company was established in 2018 by Dr. Barbara Sladek and Dr. med. univ. Nikolaus Gasche. The myBioma founding team has a background in medicine and molecular biology. Barbara Sladek has a doctorate in biochemistry (Oxford, UK) and is a qualified molecular biologist (University of Vienna). Nikolaus Gasche is a medical doctor and serial entrepreneur. myBioma has a close cooperation with the FH Technikum Wien and is part of the Lower Austrian incubator program accent.

The myBioma analysis platform was developed using analysis of algorithms containing a list of over 700 important associations between intestinal bacteria and diseases, over 3,500 scientific publications on specific microbiome issues as well as well-founded intestinal microbiome data from Central Europe.

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Contact us for further information

Barbara Sladek, PhD, MBA
Co-founder and CEO

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