Biomedical Engineering Reference
In-Depth Information
Medical Device Co Inc.
Product Design Specification
Originator
Date
Project Number / Part Number
Version:
Product Title
Summary
1. Customer:
2. Regulatory and statutory:
3. Technical:
4. Performance:
5. Sales:
6. Manufacturing:
7. Packaging and transportation:
8. Environmental:
Approved / Not Approved
Signed
Date
PDS.doc
version 1.0
Approved by:
Date: 17.5.2010
Figure 5.2
Example PDS pro forma.
It is unlikely that a PDS will be one sheet of paper. It's far more likely to be at least 10 - the
more complex the device, the more extensive the PDS.
There is no requirement to have sections. However, learning to write a PDS with sections is
advisable in order to help you remember all that should be included. Later you may find that
sectioning becomes less important than actually stating the source of the information.
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