MedSpark
Biomedical engineering and product development firm providing end-to-end services for medical device and medical electronics development, including concept assessment, multidisciplinary design and engineering, prototyping and low-volume manufacturing, regulatory and quality systems support, testing and validation, intellectual property analysis, and project management through commercialization or divestiture.
Industries
Nr. of Employees
small (1-50)
MedSpark
San Luis Obispo, California, United States, North America
Services
Design and engineering services for medical devices, implants, instruments and durable medical equipment across mechanical, biomedical, electrical and manufacturing disciplines.
User-centered industrial design, ergonomics, interface design and anthropometric analysis to support usability, safety and market fit.
Electronics architecture, circuit and PCB design, embedded firmware, FPGA development and software integration for monitoring and therapeutic devices.
Rapid prototyping, machining, molding, tooling, surface treatments, materials selection, pilot production and coordination with contract manufacturers for production scale-up.
Regulatory pathway planning and preparation (510(k), PMA, CE), development of design history files and alignment with QMS and ISO requirements.
Prototype, mechanical and pre-clinical testing including fatigue, environmental, impact, wet-lab, cadaver and in vivo testing to validate design and support regulatory filings.
Design and engineering services for medical devices, implants, instruments and durable medical equipment across mechanical, biomedical, electrical and manufacturing disciplines.
User-centered industrial design, ergonomics, interface design and anthropometric analysis to support usability, safety and market fit.
Electronics architecture, circuit and PCB design, embedded firmware, FPGA development and software integration for monitoring and therapeutic devices.
Rapid prototyping, machining, molding, tooling, surface treatments, materials selection, pilot production and coordination with contract manufacturers for production scale-up.
Regulatory pathway planning and preparation (510(k), PMA, CE), development of design history files and alignment with QMS and ISO requirements.
Prototype, mechanical and pre-clinical testing including fatigue, environmental, impact, wet-lab, cadaver and in vivo testing to validate design and support regulatory filings.
Expertise Areas
- Medical device design and development
- Embedded medical electronics and firmware
- Rapid prototyping and low-volume manufacturing
- Regulatory strategy and quality systems compliance
Key Technologies
- Computer-aided design (CAD)
- Finite element analysis (FEA)
- Computational fluid dynamics (CFD)
- Virtual prototyping and virtual engineering
News & Updates
Participation and meeting availability at the ASLMS 2018 annual meeting focused on lasers and energy-based medical devices.
Attendance and meeting availability at the SIR 2018 annual meeting for interventional radiology topics.
Presence and meeting arrangements at the ASPAN 2018 annual meeting for perianesthesia nursing professionals.
Attendance and meeting availability at the RSNA 2014 annual meeting. Blog post includes schedule and location details for the conference (Nov 30–Dec 5, 2014).
Participation and meeting availability at the ASLMS 2018 annual meeting focused on lasers and energy-based medical devices.
Attendance and meeting availability at the SIR 2018 annual meeting for interventional radiology topics.
Presence and meeting arrangements at the ASPAN 2018 annual meeting for perianesthesia nursing professionals.
Attendance and meeting availability at the RSNA 2014 annual meeting. Blog post includes schedule and location details for the conference (Nov 30–Dec 5, 2014).