Sigma Biomedical - FDA, Food and Drug Administration, Regulatory, acoustic testing, FDA consulting, FDA consultants, ultrasound testing, ultrasound test, consulting, medical devices, 510(k), ultrasound, NEMA, acoustic output measurement, standard, diagnostic, ultrasound, acoustic power measurement, testing, safety, effectiveness, MDD, medical device directive, food and drug administration, SVV, software verification and validation, sv&v, acoustic power measurement, ultrasonic, ultrasound testing, quality control, wireless monitoring, signal processing, signal analysis, diagnostic ultrasound, electronic records, acoustic output, acustic output

QUALITY AND VALUE

Where no off-the-shelf solution exists, you can leverage on Sigma’s professional and scientific team to serve your needs.
In Sigma Biomedical customer satisfaction and service quality are our goals!

EFFICACY AND
EFFECTIVENESS

Feasibility studies
Laboratory instrumentation
Research systems
Prototype development
OEM engineering
Software development
Hardware development
Signal and image processing
Mechanical design and prototyping
Product testing
Regulatory consulting
Software Verification and Validation

CUSTOMER SATISFACTION

Sigma Biomedical supports biomedical research and device development, providing custom scientific, engineering and regulatory solutions.

WELCOME!

Sigma Biomedical supports biomedical research and medical device development, providing scientific, engineering and technical services. You can leverage on Sigma’s professional and scientific team to serve your regulatory, scientific and engineering needs. Sigma Biomedical customers include medical device companies, and clinical and biomedical researchers in industry and academia. Our success is to have our ability and knowledge in your hands. Services include

510(k) Product Approval Submissions
Medical Device Testing
Product Safety and Engineering Compliance
Feasibility Studies & Prototype Development
Regulatory Affairs
Quality Systems Regulations


We listen Visualize Innovate

Team up	Design	Develop


Deliver	You Apply


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FDA, Regulatory, consulting, medical devices, 510(k), ultrasound, acoustic output, QSR, testing, safety, effectiveness, MDD, medical device directive, federal drug administration, SVV, software verification and validation, compliance, data acquisition, medical imaging, telemedicine, ultrasonic, machine vision, quality control, wireless monitoring, signal processing, signal analysis, data analysis, flow meter, position sensing, diagnostic ultrasound, electronic records, medical images, particle detector, bubble detector, noise, vibration, control, evoked potentials, accoustic output, acustic output,