Case Study | Project with EARLAB GmbH
Bringing a medical device or in-vitro diagnostic (IVD) product to market requires industry-specific expertise that startups often lack. Public funding programs such as BioMan4R2 provide founders with the necessary financial resources to work with service providers such as the MII. With the help of MII experts, three MedTech startups were able to obtain public funding totaling €27,060 – including EARLAB. The BioMan4R2 funding enabled the startup to set up its quality management system (QMS) in accordance with ISO 13485 in a service project with the MII and to build up the necessary know-how for this internally.
Our solution
The EARLAB team has a strong scientific foundation. The regulatory requirements for a legal manufacturer, on the other hand, were known, but not how they should be approached. In collaboration with the MII experts, the first step was therefore to develop the document control and hierarchy. This created clarity about the format, structure and relationships between the individual processes and the associated documents of a QMS. Subsequently, the step-by-step development of the QMS was accompanied by the MII experts and guided by best-practice examples of a QMS that was already ISO 13485-certified. In weekly meetings, the team was supported in clarifying the necessary content and scope of the documents and thus prioritizing how the certification could be achieved as quickly as possible. The results were constantly reviewed and checked for plausibility by the MII experts. It was essential to find a balance between conformity with the ISO 13485 standard on the one hand and practical applicability in the long term on the other.
Parallel to the process of setting up the QMS, the MII provided support in getting in contact with notified bodies. The opportunity to participate live in an external audit of an already certified manufacturer and the internal audits carried out by the MII with subsequent follow-ups were the ideal preparation for the upcoming assessment of EARLAB’s audit-ready QMS.
Our formats and methods
- Weekly consulting appointments with the MII consultants
- Guidance through “best practice” examples from an already ISO 13485-certified QMS
- Reviews of the independently developed documents
- Checking the documents for completeness and ISO 13485 conformity as well as practicability in everyday business operations
- Audit preparation of the team by visiting an external audit of an established manufacturer
- Implementation of internal audits incl. post-processing
The result
With the support of the MII, the EARLAB team was enabled to set up its QMS independently. This not only promotes the practicability of the QMS in its application, but also ensures that the know-how remains within the company. Through internal audits, the startup was able to identify any remaining gaps in order to be prepared for the external audit. The latter is key for the young company, as it was defined as a milestone with the investors and paves the way to becoming a certified medical device manufacturer.
“We are a startup with a high amount of research and development, so having a QMS tailored to our needs and resources is very important. The MII team is very familiar with the special demands of small companies like ours and was therefore not only able to support us in setting up a QMS tailored to our needs, but also helped us to anchor the underlying quality and customer-oriented thinking throughout the company.”
EARLAB GmbH was founded in 2017 as a spin-off of the University Hospital of Tübingen and is an innovative manufacturer of medical devices and research equipment for the objective diagnosis of hearing impairment based in Tübingen. Its goal is to provide easy-to-use and powerful hearing loss detection devices for audiologists, physicians and patients. EARLAB’s patented technology uses an innovative stimulation and analysis method that measures sound waves emitted by the ear, known as otoacoustic emissions, non-invasively in the ear canal. The method has been successfully applied in published studies on more than 300 patients.
