Sirma Medical Systems, the developer of health and telemedicine monitoring platforms - Medrec:M and Diabetes:M, has received an international quality control certificate ISO 13485:2016. The certificate is provided for the management system and related procedures in the design, development, distribution and maintenance of medical software. The international certification organization, Lloyd’s Register, has carried out the audit.
The purpose of international standard ISO 13485 is to support medical device manufacturers in creating quality management systems that establish and maintain their effectiveness. It can be applied to all manufacturers and suppliers of medical devices, components, services, and medical equipment distributors.
ISO 13485: 2016 defines the requirements for the quality management system, which sets the organization’s framework that guarantee its ability to provide medical devices and services that consistently meet customer requirements and required legal requirements.
Compared to ISO 9001, the new class of the standard differs in the next points:
- This standard is based on the specific requirements regarding medical devices
- It has a strong focus on enhanced safety and efficiency
- It ensures full compliance with legal provisions, while the ISO 9001 can be applied in unregulated proceedings
- The documentation required by ISO 13485 is much more extensive than the one needed for ISO 9001.
“The certificate acknowledges Sirma Medical Systems as a reliable supplier of software systems for medical purposes on the international market. We always strive to improve our product development work processes and quality control. It gives extra confidence to our customers, clients and partners that the company’s products and services meet the highest international requirements for quality and safety,” said Rosen Varbanov, CEO of Sirma Medical Systems.