SAFERTOS Provide rapid response for developers 、 steady 、 Deterministic embedded real-time operating system (RTOS). It contains the functions needed to develop medical devices , And provide design history documents (DHF), Integration for medical devices SAFERTOS Provide the documents required for certification .

Through the demand support for medical device developers ,SAFERTOS It can greatly reduce the project risk 、 Reduce development costs and shorten the time to market of medical devices .

“ The fact proved that ,SAFERTOS It is an ideal choice for implementing safety critical functions in medical devices . Not only because of the reliability of the software ,SAFERTOS Documentation and certification are also available , Reduce the necessary SOUP（ Unknown source software ） Workload of verification .”

– Matthias Hoelzer-Klüpfel, Independent consultant and co-founder of Certified Expert of international medical software Commission

SAFERTOS Reduce the certification time and cost of medical applications

SAFERTOS Support FDA 510(k) III Class equipment application and IEC 62304 C Class authentication .

SAFERTOS The safety manual details how to SAFERTOS Install and integrate into the medical device development environment . Follow the concise instructions in the safety manual , Keep the validation and validation performed , And there is no need to retest the target hardware for a long time .

· FDA 510(k) III Class I medical device application

· IEC 62304 C Class authentication

· TÜV SÜD Of IEC 62304 C Class criteria compliance assessment

· There is no need to retest

Platform support

SAFERTOS Support common medical platforms

· ST Microelectronics – STM32

· Texas Instruments – Hercules

· Texas Instruments – Tiva

· NXP – Kinetis

· NXP – i.MX

· NXP – MPC

· NXP – LPC

· Renesas – RX

· Xilinx – Zynq

· Atmel – SAM

Application field

Use SAFERTOS Common medical equipment

· Infusion pump

· Dialysis machine

· Prosthesis

· Hemostatic analyzer system

· Liver perfusion machine

· Ventricular assist device

· Endoscope

· cardiovascular / Hypertension monitor

· Defibrillator

· Blood glucose monitoring and dosing device

Safety guarantee

21 CFR 820 Medical design history document

SAFERTOS Design history documents conform to 21 CFR 820 The requirements of . The design history file contains specific processor / Compiler combined SAFERTOS All plans generated during development 、 Design and validation documentation .

ISO 14971 Medical device risk management

SAFERTOS The high integrity design life cycle is implemented in accordance with ISO 14971:2009“ Application of medical device risk management ” Risk management system . To ensure the SAFERTOS The design meets the safety requirements for use in medical equipment . It also allows easy integration of design history files into the medical device development environment .