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Quality Engineering
Nationwide Staffing 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.
-Developing and writing Quality Manuals, policies and procedures (SOPs)
-Risk analysis, including FMEA and FTA, and risk mitigation
-Quality Systems Management
-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
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