Quality Assurance and Compliance Services Department is committed to helping clients find the most cost-effective method for achieving quality goals and regulatory compliance. By working closely with our clients, we can design, assess and implement the systems, procedures, and documentation necessary to meet U.S. FDA Quality System regulation, ISO standards, European Medical Device Directives and Canadian Medical Device regulations.
Comprehensive quality assurance and compliance services include:

Quality system assessments & compliance audits
Corrective/preventive action programs
Design control
Risk management and design validation
Document control systems
Software quality assurance
Purchase controls and supplier quality
Customized training programs


Preparation for FDA inspections and registrar
Notified Body assessments
Enforcement action responses
Corrective action plans
Recidivist Annual Certification Audits
Recall strategies
Due diligence audits
Customized training programs
Post-Market Surveillance
Complaint handling, failure investigation
Problem reporting, device tracking
Technical file preparation for CE Marking
Manufacturing and software information for FDA

Developing and Implementing Process Validation Programs

Master validation plans
Protocol support development
Data analysis and report generation

Temporary On-Site Quality/Compliance Staffing and
Support EC Authorized Representative services