Quality Engineering
QABASA can be a one-stop shop for Design Control to Validation, for Production Control to Complaint Handling and Corrective Actions. We offer a wide range of quality assurance services to meet Federal and international requirements. We can help you develop and implement a right-sized quality assurance program to meet FDA and ISO 13485 requirements.
Our services include:
- Developing and writing Quality Manuals, policies and procedures (SOPs)
- Risk analysis, including FMEA and FTA, and risk mitigation
- Quality System training
- Supplier Evaluation and Supplier Controls
- Quality System audits and remediation (for the US, Canadian, European and international regulations for medical devices)
- Design Control managements, including retrospective Design History
- Complaint and CAPA Management, including management of Removals and Field Corrections
- Technical File and FDA submissions writing
- Production controls and process validations, including sterilization validations
- Distribution and order processing controls
- Management Reviews, and internal audits against USFDA QSR, Canadian CMDR, and EU MDD, and ISO 13485 requirements
- Efficient Management Reviews, and USFDA QSR, ISO 13485 and CMDR (Canadian) audits
- Complaint and CAPA Management, including management of Field Corrections and Removals
- Reprocessed Medical devices quality assessment
- TMV/IQ/OQ/PQ/Gauge R&R