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Manufacturing medical devices...

Manufacturing is not like the good old days- it is not simple. You no longer have a core vertical structure. Nowadays, you more likely have a confederation of suppliers, often the suppliers are competitors. Manufacturing now is now a team of suppliers to form a boutique. This organization requires more emphasis on design controls, teaming, supplier recruitment, and performance specifications.

The FDA considers all the production engineering as part of the design. They do not question if you have built one unit, they want to know that thousands of units can be built and every unit will conform to a requirements specifications and that every unit meets the stated marketing claims.

copyright by Compliance Consultants, Stamford, CT USA, September 2001