FDA Consulting - Sigma Biomedical - 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

Before marketing a medical device in the US, or reintroducing a device that has been modified affecting safety or effectiveness, medical device manufacturers need to submit to the Federal Drug Administration FDA a pre market notification or 510(k) and demonstrate by testing and documentation that it is substantially equivalent to an already marketed device and that no new safety or effectiveness concerns are introduced.



Our Uniqueness and Added Value	Sigma Biomedical goes beyond traditional regulatory consulting giving you the advantage of an engineering team that also assists in medical product development and testing. Experienced engineers who understand the product development process will work with your team so the device gets ready for submission efficiently meeting FDA regulations, saving your company precious testing time and money

Our Offer 510(k) Document Preparation Acoustic Output Measurement Doppler Sensitivity Measurement Clinical Safety and Effectiveness Software Verification and Validation Electrical Test Coordination Users Manual Preparation and Labeling Representation before FDA reviewers


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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,