Written By: Other references
Version: Date:
DESIGN INPUTS Document Number:
(Your company logo)
PREPARED BY: PRINT NAME
POSITION
SIGNATURE
DATE
Comment [PM1]: Add Au approvals information
Header – add project referen Document number etc
REVIEWED BY: PRINT NAME
POSITION
SIGNATURE
DATE
Written By: Other references
Version: Date:
DESIGN INPUTS Document Number:
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Comment [PM2]: All the i make the design possible
Design Inputs: Project Name
XXXX
Device Name
XXXX
DHF Number
XXXX
Device Description
XXXX
Regulatory Classification
US Class X subject to X EU Class X CMDR Class X
Intended Use Indications for use
What is the product, why to be used and where ?
Intended User(s)
Who can use it? Age? Sex? The purpose of use i.e. Injury, Disease etc.?
Intended Environment(s)
Where can it be used, i.e. home, clinic?
Associated devices & Complementary therapies
Any other complementary devices or accessories?
Comment [PM3]: See Reg guides, FDA website for US, C 98/79 EC or MDR 2017/745 o sources for other markets
Comment [PM4]: Ensure is aligned with other docume
Written By: Other references
Version: Date:
DESIGN INPUTS (Your company logo)
Document Number: