QQuality Engineering

RevereIT 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