Change of name to SINOVO health solutions GmbH: Clear focus on DiGA - digital health applications

SINOVO GmbH & Co. KG changed its name to SINOVO health solutions GmbH with retroactive effect from 28 December 2020. SINOVO GmbH und Co KG was transferred to SINOVO health solutions GmbH and is therefore automatically the legal successor. Read the following article to find out why the change of name was and is important.

New name with a clear focus

"The management decided on this name change in order to make the company's focus on the development of health solutions, i.e. medical apps and software, recognisable in the company name. The apps and software can be developed as medical devices (digital health applications - DiGA) in accordance with DIN EN ISO 13485 and with CE labelling, which is mandatory for manufacturers of medical apps and software in the European Economic Area.

The company is thus responding to increased customer requests for a more transparent company name. The change of name not only simplifies communication with business partners and the market; it also continues the process of market development of software as a medical product that began a good 10 years ago. Since 21 March 2010 and with the inclusion of the definition of software as a medical device in the German Medical Devices Act, the legislator has clearly regulated the requirements under which software is considered a medical device.

‘Our change of name is driven by our business partners and employees. After many discussions, it became clear that it was a logical next step to communicate our Health Solutions division more clearly, not only for all our business partners, but also for our employees, who bring this division to life every day,’ explains Jan Filip, Managing Director of SINOVO health solutions GmbH.

Responding to the emerging DiGA market and quality management challenges

‘We have mastered the development of medical apps and software as DiGA (digital health applications) for over 15 years. Now we are turning our programme into a company name. The change of name gives our company a clearer profile,’ says Filip. ‘In future, customers will recognise at first glance what they can expect from us.’

With the new name, SINOVO health solutions GmbH is also addressing the emerging market for regulated DiGA more transparently.
In recent years, more and more apps have been developed as medical devices. This development will continue to increase and emphasises the important role of apps and software in diagnostics, therapy and healthcare. With the entry into force of the EU Medical Devices Regulation, not only is the definition expanding, but the requirements for risk classes are also increasing.

SINOVO has responded to this and offers external companies quality management services based on its own experience in the approval of medical apps. Companies planning to introduce or further develop a quality management system for the development of medical apps and software in accordance with ISO 13485 receive support from the new SINOVO quality solutions unit.

For business partners, everything remains as usual for the development of DiGA

For our business partners, for whom we develop medical apps and software as DiGA, and the users of our own medical apps, nothing will change as a result of the name change, as Filip explains: ‘Everything will remain the same for our customers. Contracts, DIN EN ISO 13485 and EC certificates, contact persons, address and contact details will remain valid’.

‘We will continue our collaboration, even under the new name, with high quality and sound expertise,’ Filip emphasises in conclusion.

----

SINOVO health solutions GmbH

SINOVO health solutions GmbH is a manufacturer of software as a medical device and specialises in solutions for diabetes treatment. Founded by Jan Filip and Alf Windhorst in July 2005, SINOVO is one of the pioneers in telemedicine with innovative digital solutions. In cooperation with the team of Prof. Dr Bernhard Teupe, among others, SINOVO has developed a therapy app for type 1 diabetics based on anonymised data sets from more than 15,000 test subjects.

Press Contact

SINOVO health solutions GmbH, Tanja Schönfeld, Willy-Brandt-Str. 4, 61118 Bad Vilbel, Tel.: +49 6101 590 90 00, E-Mail: presse@sinovo.de, Web: sinovo.de