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