Medical device manufacturing is governed by FDA 21 CFR Part 820, Quality System Regulation, and/or ISO 13485 Medical Devices Quality Management System Requirements.

 

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The current good manufacturing practice (CGMP) requirements of these quality system regulations include a significant focus on establishing device design requirements and verifying manufactured devices meet requirements.  Medical device manufacturers recognize the time-consuming nature of the record-keeping for the Device Master Record (DMR) and Device History Record (DHR). In addition, the FDA Adverse Event database contains literally thousands of incidents where device manufacturers have encountered issues due to poor device design requirement identification, inspection planning and inspection documentation.

DISCUS products assist manufacturing and quality engineers with all the facets of device inspection planning and documentation production.  DISCUS enables a user to view a drawing or model and quickly identify the inspection characteristics and extract the characteristic requirements.  This identification can then be used to efficiently create manufacturing and quality assurance work products such as:

  • First Article Inspection Sheets/Reports
  • First Piece Acceptance Sheets/Reports
  • Dimensional Inspection Sheets/Reports
  • Lot/Batch Inspection Sheets/Reports
  • In-Process Inspection Planning Sheets/Reports

Depending upon the products selected, DISCUS assists with the process of identifying and extracting design requirements, followed by inspection planning and inspection sheet production, followed by inspection results collection, verification and inspection report production. Inspection sheets and reports can be customized to meet you or your customer’s format.

DISCUS reduces the labor for quality planning, inspection sheets and report production by 50% or more. DISCUS helps you quickly analyze and interrogate the part – whether it’s in the form of a 2D drawing or 3D CAD model. DISCUS helps to organize many of the documents pertinent to the DMR and helps to analyze the part drawings/models to easily identify and document the characteristics and acceptance criteria. The result is greatly improved productivity in manufacturing and quality engineering.