ISO 14971
ISO 14971 is the internationally accepted application of a risk management process for medical devices. It Sterling’s experts can provide companies with assistance for the ISO 14971 application.
- Risk analysis, evaluation, mitigations, and a residual risk analysis and management
- Analysis of hazardous factors including viruses
- Providing support and documentation needed for your ISO 14971 application
Once to market, reliable ISO 14971 compliant risk management assures consumers that the industry approved product will provide a positive experience that is best suited for the nature of their intent.
About Sterling Medical Devices
Sterling Medical Devices specializes in the design, development, and test of medical devices. Sterling addresses every aspect of the development process: software, electronics, mechanical, quality, and compliance. Our goal is to make sure you get the FDA approval and CE Marking you need to bring your device to market. Sterling Medical Devices has developed more than 1,000 medical device products for over 300 companies, ranging from Class II diagnostic and therapeutic systems to Class III implantable devices, using embedded systems, PC based devices, smartphones/tablets, and web/cloud services. We are proud to have worked with such prestigious organizations as Covidien, St. Jude Medical, Medtronic, Boston Scientific, Johnson & Johnson, and many more. We also partner with early-stage companies to help them bring new products to market. In every case, we produce the right product in the right time frame with the right budget.
