OpenWT is now certified according to EN ISO 13485:2016 and thereby approved for the design, development and deployment of software and mobile apps for medical devices with their Medical Excellence Unit.
Stephan Kraus, Associate Partner and Market Manager in Zurich said: “We are proud to receive the ISO 13485 certification that demonstrates how OpenWT has adopted best practices in quality management in software development. With medical device manufacturing being one of the most heavily regulated sectors, passing the ISO 13485 certification demonstrates our commitment to the quality and safety of the software we build for our clients.”
OpenWT has received the certification from DNV, one of the world’s leading classification societies and a recognized advisor for businesses on how to advance quality, safety and set industry benchmarks to tackle global transformations.
The challenges digitalization brings to the health sector
Digitalization offers endless possibilities to improve the patient experience. From allowing patients to quickly see a doctor without leaving their homes to improving organ donation algorithms, there are many opportunities enabled by new and emerging technologies. However, the healthcare sector is heavily regulated and focused on not compromising the clinical condition or the safety of patients. Introduced in May 2021, the Medical Device Regulation has been expanded to cover a range of products to include many software applications used by patients directly. To release most software for medical devices, both the legal manufacturer and key suppliers for software development must demonstrate to a notified body that they have a quality management system compliant with ISO 13485.
The advantages of high quality standards
At OpenWT, we take pride in our strong proven agile processes to design, develop and deploy software for many years. Quality is utmost important to our business, most particularly for our customers in the health-care sector. We continuously strive to provide our customers with products and services which meet and even exceed their expectations. Our team of experts within the Medical Excellence Unit, specifically trained to satisfy the requirements of ISO 13485:2016 for our products and services related to medical products, is there to ensure the effectiveness of our Quality Management System. Therefore, the receipt of this international standard is an important milestone in our development of software to support our healthcare clients in digitalize Switzerland’s healthcare system and recognizes our forward-thinking approach in the emerging digital health sector.
The superpower of app modernisation
Today, many existing solutions are used in hospitals and other healthcare system which may fall under the newly introduced Medical Device Regulation. Learn more about how we can support you to modernize an application and doing so by being compliant with new norms, certifications and technologies on our dedicated focus page.