Vincit has been awarded the ISO 13485 quality certificate. ISO 13485 is an international management system standard for the design and development of medical devices and supplies including medical software. Vincit already has a strong customer base in the health technology and pharmaceutical industries, and the new quality certificate enables deeper cooperation with both domestic and international medical device manufacturers and pharmaceutical industry players.
Vincit has implemented dozens of projects for companies operating in the healthcare industry as well as the public sector. The certification allows us to deepen product development cooperation with medical device manufacturers by enabling outsourcing of entire software development parts of medical projects to Vincit.
ISO 13485 certification strengthens Vincit's role as a product development partner and also enables the growth of international business in the medical device industry. The quality management system has been built, where applicable, to use Vincit's existing ISO 9001 management system, which brings Vincit's extensive software design and development expertise to medical device projects.
The certificate covers the design and development of contract-based embedded software for medical devices and in addition, the design and development of stand-alone and cloud-based medical software for the health technology and pharmaceutical industries for both public and private sector healthcare providers. The aim of the certification is also to bring agile development methods, data driven development and software know-how into the regulated health technology industry.
High-quality design and development of medical devices requires a management system based on the ISO 13485 standard. The standard complies with EU regulations for medical devices and helps device manufacturers reduce device risks and improve their reliability. The certified ISO 13485 quality management system ensures that the tools, processes and measures used in the medical software projects comply with the health service regulations, and helps to ensure production of high-quality and safe medical devices.
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