Quality Assurance
HR’s Quality Assurance Program is designed around robust FDA Medical Device and OTC requirements and can be optimized for your market’s requirements.
HR’s Quality Assurance team provides complete oversight and monitors all services, processes and manufacturing from raw material inspection and finished goods inspection, to work in progress, process and testing. Our Quality Assurance Program is designed around robust FDA Medical Device and OTC requirements and can be optimized for your market’s requirements.
HR has many systems in place to ensure quality during the process and production of every product. All operations are supervised by trained quality control specialists and undergo rigorous validation and safety checks. All production runs are in compliance with cGMP, FDA regulations, and customer requirements.
- Inspection Criteria
- UDI Compliance
- Quality Management Software System (QMS)
- CAPA Program (Corrective And Preventive Action)
- Detailed Standard Operating Procedures Training Program
- Robust In-Process Testing & Verification Systems
FDA Registered
cGMP Compliant
ISO 13485
MDSAP
Health Canada
