Sigma Biomedical
Sigma Biomedical is a comprehensive provider of regulatory consulting, product development, testing, and quality management services for the medical device industry. Their mission is to help companies achieve compliance and market their products efficiently in the US and international markets, leveraging their engineering expertise and regulatory knowledge.
Industries
Nr. of Employees
small (1-50)
Sigma Biomedical
123 Biomedical Ave, City, State, ZIP
Services
End-to-end regulatory services including product analysis, predicate search, submission preparation, filing and interaction with regulatory authorities for market clearance.
Coordination and execution of safety and performance tests across electrical, EMC, biocompatibility, mechanical and acoustic domains to support regulatory submissions.
Autoscanning/non-autoscanning acoustic output measurement, beam profiling, hydrophone calibration and comprehensive test reports suitable for regulatory submissions.
Validation of repair processes for ultrasound transducers including pre/post performance testing, imaging quality assessment and support for regulatory filings where required.
QMS gap analysis, implementation planning, employee training, mock audits and ongoing QMS support aligned with ISO 13485 and FDA QSR.
Contract R&D services including feasibility, prototyping, electronics, mechanical design, embedded software, signal processing and system integration for medical products.
End-to-end regulatory services including product analysis, predicate search, submission preparation, filing and interaction with regulatory authorities for market clearance.
Coordination and execution of safety and performance tests across electrical, EMC, biocompatibility, mechanical and acoustic domains to support regulatory submissions.
Autoscanning/non-autoscanning acoustic output measurement, beam profiling, hydrophone calibration and comprehensive test reports suitable for regulatory submissions.
Validation of repair processes for ultrasound transducers including pre/post performance testing, imaging quality assessment and support for regulatory filings where required.
QMS gap analysis, implementation planning, employee training, mock audits and ongoing QMS support aligned with ISO 13485 and FDA QSR.
Contract R&D services including feasibility, prototyping, electronics, mechanical design, embedded software, signal processing and system integration for medical products.
Expertise Areas
- Regulatory compliance and submissions (510(k), PMA)
- Medical device safety and performance testing
- Ultrasound acoustic measurement and transducer validation
- Quality management systems (ISO 13485, FDA QSR/21 CFR 820)
Key Technologies
- Diagnostic ultrasound field characterization
- Hydrophone-based acoustic measurement
- ISO/IEC 17025 laboratory testing
- IEC 60601 electrical safety testing