ISO 13485 Certification for Medical Devices

Development according to requirements and international standards in ISO 13485 for Medical Devices

In order to be allowed to use medical products such as software and hardware for laboratory diagnostics, they must comply with defined legal requirements. In addition, international norms ensure comparable standards in the international arena and enable optimal comparability of measurement data. Kapelan Bio-Imaging develops medical products that comply with the requirements of ISO standard 13485 in all processes. This quality management system covers the design as well as the manufacture and marketing of medical devices and ensures an international standard at the highest level. In particular, the secure storage of sensitive data is a focus of the certified product safety for medical IT.

The entire development process carried out by Kapelan meets the relevant requirements of IEC 62304. It also involves risk management in accordance with ISO 14971. This guideline specifies the procedure by which possible hazards and risks must be assessed, evaluated and controlled during all phases of the product. These requirements are indispensable for agile software development with SCRUM. Usability is also an important aspect of security. It is based on the international IEC 62366 standard for all products developed by Kapelan. The aim of this standard is to minimize the risk of using a medical device by making it easy to use and easy to learn.

Through compliant development according to all legal and technical requirements, all products from Kapelan Bio-Imaging, including services, documentation, software files, support/maintenance and IQ/OQ, meet the highest international standards.