Samaras & Associates
Samaras & Associates is a healthcare engineering private practice dedicated to helping develop and deploy safe, effective, efficient, and satisfying medical devices and health information systems. With a focus on regulatory, quality, risk management, human factors, and mechatronics, they serve domestic and international clients since 1997, offering personalized services and expert consultation in medical device development, regulation, and safety. The company also has a strong background in human-centered systems engineering, ergonomics, and healthcare policy, with extensive experience in research, publications, and professional activities.
Industries
Nr. of Employees
small (1-50)
Samaras & Associates
7755 Soda Creek Road, Red Creek Ranch, Pueblo, CO 81005-9763 USA
Products
Patents and technical inventions associated with principals
Selected issued patents covering medical measurement and signal-processing techniques relevant to physiological measurement and noise-immune sensing.
Selected publications and technical reports
Peer-reviewed articles, conference proceedings, technical reports, and workshop materials on human-centered systems engineering, validation engineering, clinical research, and occupational health.
Patents and technical inventions associated with principals
Selected issued patents covering medical measurement and signal-processing techniques relevant to physiological measurement and noise-immune sensing.
Selected publications and technical reports
Peer-reviewed articles, conference proceedings, technical reports, and workshop materials on human-centered systems engineering, validation engineering, clinical research, and occupational health.
Services
Consulting on preparation and submission of US regulatory filings (510(k), IDE, PMA, de novo, classification requests), establishment registration/device listing, MDR reporting, inspection response, and related regulatory documentation.
Development, implementation, and auditing of FDA-compliant QMS and design control systems, including SOPs, work instructions, and integration of engineering and quality practices.
Comprehensive hazard and risk analyses consistent with ISO 14971, selection and verification of mitigations, and development of regulatory-aligned risk documentation across hardware, software, and human factors.
Task and function analysis, formative and summative usability testing, labeling studies, clinical use evaluations, and integration of HF&E findings into risk management and verification/validation artifacts.
Technical and management support to integrate mechanical, electrical, software, and human factors engineering disciplines, including maturity assessments and engineering management improvements.
Design and execution of statistically-defensible V&V protocols, software validation, usability validation, and guidance on appropriate sample sizes and statistical methods for regulatory submissions.
Consulting on preparation and submission of US regulatory filings (510(k), IDE, PMA, de novo, classification requests), establishment registration/device listing, MDR reporting, inspection response, and related regulatory documentation.
Development, implementation, and auditing of FDA-compliant QMS and design control systems, including SOPs, work instructions, and integration of engineering and quality practices.
Comprehensive hazard and risk analyses consistent with ISO 14971, selection and verification of mitigations, and development of regulatory-aligned risk documentation across hardware, software, and human factors.
Task and function analysis, formative and summative usability testing, labeling studies, clinical use evaluations, and integration of HF&E findings into risk management and verification/validation artifacts.
Technical and management support to integrate mechanical, electrical, software, and human factors engineering disciplines, including maturity assessments and engineering management improvements.
Design and execution of statistically-defensible V&V protocols, software validation, usability validation, and guidance on appropriate sample sizes and statistical methods for regulatory submissions.
Expertise Areas
- Regulatory compliance for medical devices (510(k), PMA, IDE, de novo, MDR)
- Quality management systems and design controls (FDA QSR, ISO 13485)
- Risk management and ISO 14971 implementation
- Human factors and usability engineering
Key Technologies
- Embedded software development
- Mechatronics (hardware/software integration)
- Human factors and usability engineering methods
- Formative and summative usability testing
News & Updates
Risk Management Workshop, Washington, DC. September 18, 2016.
AAMI Biomedical Instrumentation & Technology, 52(4): 296-304, July/August 2018.
Presented at IEEE Healthcare Innovation Conference, Houston, TX, November 7-9, 2012.
Risk Management Workshop, Washington, DC. September 18, 2016.
AAMI Biomedical Instrumentation & Technology, 52(4): 296-304, July/August 2018.
Presented at IEEE Healthcare Innovation Conference, Houston, TX, November 7-9, 2012.