The world’s first double certification in microbiome analysis
We are delighted that myBioma, our Austrian portfolio startup, is the first health tech company in the field of microbiome analysis worldwide to achieve double certification – both 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.
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.
Believing in European talents
This great achievement also underlines the importance of what’s the core mission of ESAC is – to support and showcase European talents and their growth stories.
“We are very proud of what Barbara and Nikolaus and the whole team at myBioma accomplished! It’s required tremendous dedication from their end and we’ve been glad to have been working with and supporting them along the way. I’m confident that we will see even more amazing progress and results from them in the future in personalising patient treatments ” – added Berthold Baurek-Karlic, President of ESAC.
Two-stage audit in February 2020
The renowned certification body MDC (medical device certification GmbH) carried out a two-stage audit in February 2020 and the decision was shared last week. 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 fulfillments 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 standardised 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 optimise 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.
The next stop to meet European startups
If you are interested in getting to know deal flows with similar high growth potential, then make sure you register for the kick-off event of this year’s ‘Invest and Connect’ exclusive startup award series! The series begins with the French national qualifier on 4th June (17:30) and for the first time in the history of ‘Invest and Connect’, it will take place online. The 5 pre-selected and pre-assessed French startups from the field of smart mobility are busy rehearsing their pitches to present in front of a jury of European investors from across the continent. Important! – It’s a private-banking-type of event; hence, seats are limited!
EAGER TO LEARN MORE FIRST HAND? LOOKING TO EXTEND YOUR INVESTORS NETWORK?
Then register today to secure your spot at the kick-off Paris virtual event!
In line with the club’s exclusive profile we welcome registration from qualified investors. All applications are subject to approval. Early-bird rates expires less than two weeks – make sure you register today!
However, access to all Invest and Connect event is included in the ESAC Membership offer and event admission is FREE OF CHARGE for all members.
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