. About US: InterSources Inc. is a Small, Woman, and Minority-Owned Business Enterprise, ISO/IEC 27001, SOC 2 Type 2 certified company...
and applicable regulations. Organizes and ensures IEC/HA approvals, if applicable, and ensures that the trial is in compliance...
and hardware development, including knowledge of standards such as IEC 60601, ISO 13485, ISO 14971. Preferred Experience...
regulations (e.g.IEC 62304, FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CAP, and CLIA...
Services (DDS), e.g. (RTI Connext, OpenDDS, MQTT, or similar distributed data sharing libraries). Experience with IEC 60601-1..., 60601-1-2, IEC 60601-2-2, IEC 62304, etc. and relevant standards within Medical Devices, or equivalent standards...
Guidance and IEC 81001-5-1. Understanding of Bluetooth technology. Awareness of HIPAA and GDPR compliance practices. ASQ...
, and Minority-Owned Business Enterprise, ISO/IEC 27001, SOC 2 Type 2 certified company with massive 18+years of diversified...
devices and mobile apps. Ensure adherence to medical device standards such as ISO 13485, IEC 62304, and FDA regulations...) as well as application-level development. Familiarity with medical device regulations (FDA, ISO 13485, IEC 62304). Hands...
site quality management system in accordance with ISO/IEC 17025 requirements, company SOPs, and corporate guidelines... (guides, job aids, presentations, assessments) and ensure content remains current with ISO/IEC 17025 requirements, company...
standards (e.g., IEC, UL, NEC), and safety guidelines. Update and maintain existing wiring diagrams and technical documentation... of electrical systems, circuit design, and wiring practices. Familiarity with industry standards and codes (e.g., UL, NEC, IEC...