Dave Martin in the blog “Yes, Model-Based Definition Can Work in Regulated Industries” discusses about the following

After a recent blog post I wrote on model-based definition (MBD) on the PTC website, I received the following email:

I am curious to hear your thoughts on MBD in medical devices and other regulated industries. In med device, the print is:

  • a legal contract between manufacturer and company
  • an inspection document (for first article as well as lot inspection, controlled by AQLs for critical dimensions, as dictated by risk analysis)
  • an FDA-auditable design artifact (“design history record”)

Its use as a manufacturing and design document is dwarfed by the legal and regulatory aspects.

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