News

ISO certification for development of medical devices – Appsfactory guides clients safely through the processes

Appsfactory has been advising manufacturers on the development and approval of software as a medical device in accordance with ISO 13485 since August 2020. Information on all services is now available on the company’s newly launched Medical Website.

A quality management system in accordance with ISO standard 13485 is required for the manufacture of medical devices. Various European directives and ordinances such as the Medical Device Regulation (MDR) regulate strict requirements for the manufacture and market launch of medical devices, with patient safety being the top priority.

In order to meet the standards, a quality management system (QMS) is necessary. This consists of a multitude of processes and documentation which the company must comply with and produce. In addition, technical documentation is created during the manufacture of medical devices, which must also be available as administrated documents. A company can only begin developing medical devices when these systemic requirements are fulfilled and ISO certification according to 13485 is available.

As Thomas Voß, Product Team Lead & Medical Quality Management Officer at Appsfactory explains: “We, as a consulting and implementation agency, did not want to miss the opportunity to meet the standards of ISO 13485 ourselves and to obtain the certification. This considerably simplifies the medical device development process for our customers and enables us to provide them with comprehensive advice – also in terms of the IEC 62304 (software development) and ISO 14971 (risk management) standards. We also provide an excellent overview of the different phases on the way to a functioning and certified QMS. Along with this, we show our customers which tools are suitable for implementation.”

Dr Rolf Kluge, CTO of Appsfactory, continues: “The medical sector and our own certification represent an important step for Appsfactory, as this enables us to present our own quality standards transparently to everyone. In this way, we have already been able to win strategically important customers such as AOK, Beurer, Karl Storz, Ottobock and Weisse Liste. We naturally hope that other important members of the medical industry will entrust us with the certification of their products.”

The medical division at Appsfactory will be further expanded in the coming years in order to develop safe and reliable software for medical devices. By 2025, the company seeks to employ 80 experts in the field and reach the 10 million EUR turnover mark.

28. June 2021
13. June 2022

Leipzig, 13 June 2022 – The DKV Mobility app developed by DKV Euro Service and Appsfactory has won two awards at the German Brand Awards in the categories “Excellence in Brand Strategy and Creation” and “Brand Efficiency of the Year”. “We are delighted that our long-standing partnership with DKV Euro Service has been recognised with […]

2. June 2022

Munich, 2 June 2022 – Appsfactory has been a certified Livingdocs partner since January 2022. Livingdocs is the provider of a content creation and publishing system. Appsfactory provides media customers with certified experts who offer holistic solutions ranging from consulting to implementation. These can be tailored precisely to the individual needs and challenges of the […]

23. May 2022

Leipzig, 23 May 2022 – Appsfactory and the Saxony Police Administration Office will be represented at the GPEC (General Police Equipment Exhibition & Conference®) in Frankfurt am Main from 31 May to 2 June 2022. Among other things, the two innovation partners will present ASEL – an intelligent speech recognition system. The intelligent speech recognition […]

10. May 2022

Leipzig, 10 May 2022 – Dr Alexander Trommen, Appsfactory’s CEO, is a guest in panel discussion on “New Work – New Professional Worlds” at “Zukunftsland Sachsen”, a digitalisation platform initiated by the Free State of Saxony and the Leipzig Graduate School of Management (HHL). The discussion will be taking place at SpinLab, Leipzig, from 4:00 […]

3. May 2022

Leipzig, 3 May 2022 – Appsfactory wins four golden German Stevie® Awards for the news application “KSTA – Nachrichten”. The app was a joint development with the Cologne-based daily newspaper Kölner Stadt-Anzeiger. Success in relevant categories This year, the more than 400 applications were evaluated by around 50 jurors sitting on five committees. The news […]