Links
• 21 CFR 820.30d: [ Ссылка ]

• ISO 13485:2016 Section 7.3.4: [ Ссылка ]

• Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
o Chapter 5
o Tasks 7 & 8

• Design Control Guidance For Medical Device Manufacturers: [ Ссылка ]

• Design Controls, Joseph Tartal: [ Ссылка ]

• GHTF Design Control Guidance for Medical Device Manufacturers (Replaced by ISO 14969:2004): [ Ссылка ]

• The Art of Defining Design Inputs and Design Outputs, by Jon Speer, January 8th, 2020: [ Ссылка ]

Requirement name and location
Our requirement, Design Output, comes directly from 820.30d and 13485 Section 7.3.4.

Design Output requirement in 5 words:
Create Design Outputs Fulfilling Inputs

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