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.