Implement a Digital Quality Management System in your organization and control the quality of your processes.
As a medical devices company you help improve health and quality of life by innovating and accelerating high quality research.
With BizzMine you have validated QMS software according to international standards.
Adopting ISO 13485 is demonstrating a commitment to the safety and quality of medical devices. The certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. The required processes are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
ISO 14971 allows you to identify the hazards associated with the medical device and to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. To ensure your company gets a safe, effective product to market on time and within budget, you need a successful implementation of your risk management system.