Rallis-Daw Consulting
Medical device consulting firm based in San Clemente, CA providing regulatory, quality, clinical, and project management services. Core offerings include implementation and management of electronic quality management systems (eQMS), regulatory submission support and intelligence, audit and remediation services, technical writing, validation and statistical support, clinical site services, and end-to-end product development support from concept to market.
Industries
Nr. of Employees
small (1-50)
Rallis-Daw Consulting
San Clemente, California, United States
Products
Managed electronic Quality Management System (eQMS) service
Subscription-based managed eQMS service that provides QMS creation, document and record control, training management, design control, audit management, CAPA, risk management, supplier management, regulatory submission intelligence and equipment management.
Concept-to-market development program
Structured program providing a dedicated project manager, access to technical resources, partnerships with contract manufacturers and test labs, regulatory guidance, and post-market surveillance support to bring medical device concepts to market.
Ablest-eQMS
A comprehensive electronic Quality Management System (eQMS) program powered in partnership with Cognidox, designed to handle development, implementation, maintenance, and compliance for highly regulated organizations.
QMS/eQMS Implementation and/or Management
Consulting and management services for quality management systems and electronic quality management systems.
Strategies
Medical device regulatory consulting and strategy services.
Audit Execution
Audit consulting and execution services including MDSAP, EU MDR, ISO 13485:2016, QMSR, Sterilization, AS 9100D, and ISO/IEC17025.
Managed electronic Quality Management System (eQMS) service
Subscription-based managed eQMS service that provides QMS creation, document and record control, training management, design control, audit management, CAPA, risk management, supplier management, regulatory submission intelligence and equipment management.
Concept-to-market development program
Structured program providing a dedicated project manager, access to technical resources, partnerships with contract manufacturers and test labs, regulatory guidance, and post-market surveillance support to bring medical device concepts to market.
Ablest-eQMS
A comprehensive electronic Quality Management System (eQMS) program powered in partnership with Cognidox, designed to handle development, implementation, maintenance, and compliance for highly regulated organizations.
QMS/eQMS Implementation and/or Management
Consulting and management services for quality management systems and electronic quality management systems.
Strategies
Medical device regulatory consulting and strategy services.
Audit Execution
Audit consulting and execution services including MDSAP, EU MDR, ISO 13485:2016, QMSR, Sterilization, AS 9100D, and ISO/IEC17025.
Services
Design, implement and maintain electronic QMS solutions; ongoing managed subscription service to operate a client's QMS and support regulatory readiness.
End-to-end program management from ideation through regulatory submissions, prototyping coordination, testing, and market entry with post-market support.
Regulatory planning, preparation of submissions and intelligence tracking to align products with current global requirements.
Internal and supplier audit execution, audit management, and remediation planning to address findings and improve compliance.
Develop validation and verification plans and provide statistical analyses to support product development and regulatory submissions.
Site qualification, monitoring, study audits and TMF/eTMF preparation and maintenance for clinical investigations.
Design, implement and maintain electronic QMS solutions; ongoing managed subscription service to operate a client's QMS and support regulatory readiness.
End-to-end program management from ideation through regulatory submissions, prototyping coordination, testing, and market entry with post-market support.
Regulatory planning, preparation of submissions and intelligence tracking to align products with current global requirements.
Internal and supplier audit execution, audit management, and remediation planning to address findings and improve compliance.
Develop validation and verification plans and provide statistical analyses to support product development and regulatory submissions.
Site qualification, monitoring, study audits and TMF/eTMF preparation and maintenance for clinical investigations.
Expertise Areas
- Quality management system (QMS/eQMS) implementation
- Regulatory strategy and submissions (FDA, EU MDR/QMSR)
- Audit execution and remediation
- Risk management and CAPA
Key Technologies
- Electronic quality management systems (eQMS)
- Regulatory intelligence and monitoring systems
- TMF/eTMF management
- Validation and verification methodologies
News & Updates
Discussion of internal audit findings handling, root-cause analysis, CAPA selection and verification activities in the context of ISO 13485 requirements.
Overview of regulatory audit execution, risk management considerations, and the role of CAPAs in continuous improvement.
Summary of focus areas for the year including technical writing, validation planning, statistical analyses and test laboratory sourcing strategies.
Article describing the managed eQMS offering, its subscription model, and included QMS capabilities.
Discussion of internal audit findings handling, root-cause analysis, CAPA selection and verification activities in the context of ISO 13485 requirements.
Overview of regulatory audit execution, risk management considerations, and the role of CAPAs in continuous improvement.
Summary of focus areas for the year including technical writing, validation planning, statistical analyses and test laboratory sourcing strategies.
Article describing the managed eQMS offering, its subscription model, and included QMS capabilities.