| Certificate/Reg.-No. | 968/FSP 1816.00/19 |
| Type of Certificate | A-FS&CS Certificate |
| Certificate Holder | QNX Software Systems Limited |
| Manufacturer | QNX Software Systems Limited |
| Product Category | Software > RTOS |
| Subject | Real Time Operating System (RTOS) |
| Type Designation | QNX OS for Medical (QOSM) for released and approved versions refer to the "Revision List" |
| Codes and Standards |
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| Scope and Result | The QOSM product complies to the applicable requirements of IEC 62304 Class C and can be used in medical devices complying with the requirements of IEC 62304 at software safety class A, B or C. |
| Specific Provisions | For the use of the QOSM the operating conditions and functional characteristics as specified in the Safety Manual and accompanying documents provided by the manufacturer needs to be observed. The current versions of software are specified in the currently valid revision list. The list is released by the manufacturer in cooperation with the Certification Body. The risk management according to ISO 14791 required by standard IEC 62304 is excluded from scope of the certification. These process activities need to be established by the medical device manufacturer of a product while developing a medical device. |
| Valid Until | 2024-02-08 (Certificate expired) |
| Appendixes |
FSP_1816_00_19_RL_2019_02_08.pdf FSP_1816_00_19_RL_2021-11-26_QOSM_2_0_1.pdf |
| Download Certificate | 968_FSP_1816_00_19_en_el.pdf |
| Certificate/Reg.-No. | Certificate Holder | Product Category | Product Tested | Type Designation | Details |
|---|
| 968/FSP 1816.00/19expired | QNX Software Systems Limited | Software → RTOS | Real Time Operating System (RTOS) | QNX OS for Medical (QOSM) for released and approved versions refer to the "Revision List" | View Details | View PDF |
Remark: In case of missing entries this is due to restrictions by the certificate holder
