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Software Regulatory Services

Sigma Biomedical provides Information Technology and Regulatory Compliance services to Pharmaceutical, Biotechnology, Chemical and Medical Device Industries. The firm's dependable suite of services and solutions enables its Life Sciences clients to bring products to market sooner; thereby, improving manufacturing efficiency and achieving compliance with Food & Drug Administration (FDA) and other global regulatory bodies.

Our Services

Sigma Biomedical operates under very experienced leadership. Each member of the team possesses an average of 18 years of industry expertise, most of which have been dedicated to Pharmaceutical, Biotechnology and Medical Device sectors.

Sigma is fully prepared to offer Information Technology and Regulatory Compliance Solutions via the following services:

-     GxP and 21 CFR Part 11 Assessments
-     GxP and 21 CFR Part 11 Training
-     Computer System Validation (CSV)
-     21 CFR Part 11 Remediation.
-     Automated Equipment and Analytical Instrument   Qualification.
-     Automated Equipment and Analytical Instrument Validation.
-     Consent Decree Orientation and Remediation.


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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,