Fit for ISO 13485! Quality management for medical apps as a success factorErfolgsfactor

Medical apps are part of many people's daily lives, and in some cases the success of therapy depends on them. The ISO 13485 standard therefore rightly sets a high quality standard. In particular, the standard promotes continuous quality management. From conception and app development to distribution and after-sales services, quality management plays a crucial role in every phase of a medical app's life cycle.

ISO 13485 is mandatory for medical app manufacturers in the European Economic Area. Its core objective is product safety and legal compliance.

The number of medical apps on the German market is still limited. Of almost 9,000 health apps with a German app description, only about 100 have a CE marking. [1]

Risk class for medical apps is increasing – and with it the challenges

From 2021, more apps will be considered medical devices. With the entry into force of the EU Medical Device Regulation, not only is the definition expanding, but the risk class is also increasing. Some medical apps and software will then be in the same risk class as ventilators.

Developers of medical apps must therefore prepare for significantly higher requirements. Until now, an app or software was considered a medical device if it had a diagnostic or therapeutic approach. With the EU Medical Device Regulation, software that provides a prognosis will also be included from 2021. This is defined in the Medical Device Regulation, which will be replaced by the Medical Device Directive in the future.

From the point of view of medical app developers, there are now a number of challenges to be overcome. Quality management supports the manufacturers in this process. Johann Wolfgang von Goethe once said: “You can build something beautiful even out of the stones that are put in your way.” In today's challenging environment, Jan Filip, Managing Director of SINOVO, says: “An effective QM system according to ISO 13485 is an ideal ‘app’.” - a blueprint for meeting current and future legal requirements in the field of medical apps.”

Take on the challenges & overcome them with the new QM services from SINOVO

SINOVO has responded to the challenges and now offers companies services in the field of quality management for the development of medical apps and software according to ISO 13485 if they are planning to introduce or further develop a quality management system.

The aim is to support companies and medical device manufacturers in developing apps and medical software in compliance with the law and standards, in setting up lean QM systems and in passing QM audits with flying colors (quality.sinovo.de).

Companies that want to bring an app to market as a medical device can hardly avoid setting up a quality management system certified according to ISO 13485. Therefore, many of them strive for ISO 13485 certification. To achieve this, they must, above all, review and adapt their own processes – and should not underestimate the effort involved in gap analyses, process optimization, documentation and the actual certification audit. SINOVO's QM team takes over these tasks for companies.

Successfully place medical apps on the market with certified quality management

Companies that manage to have their QM system certified according to ISO 13485 and launch their medical app with CE marking have significantly less competition. Most manufacturers do not make it as far as mentioned at the top of the introduction. Therefore, medical app manufacturers should see the effort for a certified QM system as an opportunity to secure a long-term place in the market for digital health applications.

In this way, SINOVO supports companies very well and safely based on its experience. SINOVO has already developed many different apps as medical devices for customers. The developed apps are not only safe and reliable, but also pass the audit of the notified bodies.

Experienced QM consultants for your ISO 13485 QM system – on-site or remote

For their QM projects, customers receive trained and experienced QM consultants at their side for support. Our QM consultants are committed to being there for you, providing you with the right support and finding sustainable solutions for challenges.

Our QM team works in a precise, fast and structured manner so that the customer's project costs remain within an economically reasonable range. Flat hierarchies and team spirit provide the necessary freedom for this. „We always combine our theoretical knowledge with practical experience. This enables us to offer customers practical solutions”, says Filip.

Certified QM system according to ISO 13485 – added value for companies and their customers

2,743 companies in Germany have introduced a quality management system in accordance with ISO 13485 and have been certified [2] . Implementing ISO 13485 offers advantages that have a positive impact on the business success of companies and on market and customer expectations:

• Compliance with medical device guidelines and customer expectations,
• documented manufacture of safer and more effective medical devices,
• optimization of internal processes in the company by describing the tests,
• increasing efficiency and reducing costs.

SINOVO Health Solutions GmbH

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

Presse 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

[1] Studie der Medizinischen Hochschule Hannover, 2018, https://mhealth.jmir.org/2018/4/e10394/

[2] Die ISO-Umfrage zu Managementsystem-Standardzertifizierungen 2019