Technical Capabilities
Devicix is an ISO 13485 and 14971-certified, multi-disciplinary engineering firm that delivers innovative design solutions and comprehensive product development services. Our exclusive focus is the medical device industry. We create Class I, II and III medical devices in numerous medical specialties including but not limited to: point-of-care diagnostic instruments, therapeutic devices, implantable devices and monitoring equipment. Devicix brings the foremost concept and product development expertise to early-stage and established medical device manufacturers, physicians, entrepreneurs and universities, allowing them to compete and win in today's highly competitive, complex and heavily regulated global marketplace.
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Electrical Design (PDF) • Embedded systems • Motion control applications • Custom boards • Microcontroller and DSP • FPGA development • Test fixtures • Electrical safety and compatibility |
Mechanical Design (PDF) • Medical instruments and enclosures • Medical disposable sets and packaging • Manual, pneumatic, and electric pumps and valves • Broad material utilization and process application • Solid modeling |
| Software Development (PDF) • Embedded and RT software • User interface development • Desktop applications • Software Verification and Validation |
Quality Assurance (PDF) • Project management • Requirements management • Safety risk management • Concise test plans and reports • International standards (ISO, ANSI, AAMI) • System/sub-system verification and validation • Detailed design documentation |
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Manufacturing (PDF) • Mechanical & Electromechanical medical device assembly • Process Development & Validation • Test & Inspection • Prototypes to clinical builds to production volumes. • Package design and validation. • Worldwide shipping and servicing. |
Complete Systems • Concept generation • Rapid prototype development • Proof of concept |
