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Medical Industries
Medical device manufacturing is governed by 21 CFR Part 820 (and/or ISO 13485) with oversight provided in the US by the Food and Drug Administration (FDA – www.fda.gov). Part 820 requires a great focus on establishing and complying with design requirements
Medical device manufacturers working to comply with Part 820 recognize the time-consuming nature of the record-keeping for Good Manufacturing Practices (GMP). The FDA can audit approaches for GMP at any time with a focus on the alignment between 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 first article inspections.
The DISCUS core competency is managing a part’s Technical Data Package at the characteristic level of detail. DISCUS enables a user to view a drawing or model and quickly identify the features and characteristics. This identification can then be used to efficiently create downstream artifacts for manufacturing and quality assurance. This includes First Article Inspections, In-Process Inspection Plans, Manufacturing Process Plans, and Producibility Analyses.
DISCUS enables suppliers to manage the detailed device characteristics associated with the DMR and DHR, and reduces labor for quality planning and first article inspection by more than 50%. DISCUS helps you to quickly analyze and interrogate the part – whether it’s in the form of a 2D drawing on 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 attributes and acceptance criteria. The result is greatly improved productivity in manufacturing and quality engineering. For example, DISCUS has consistently increased FAI and SPC productivity by more than 50%.
