Biomedical Engineering Reference
In-Depth Information
5 Sales:
5.1
Sales cost c £40 (gross margin
60%)
Sales report
5.2
Estimate 100 sold per month
Sales report
5.3
Should fit in std Jacob's Chuck
Sales report/follow-up focus group
5.4
Packaging to be minimal
Sales report
5.5
Would be good to have a mark
every 5 mm between 60-90 mm to
estimate hole depth (UPS against
other drills)
Sales report
5.6
Can it be gold in color to match
market leader?
Sales report
6 Manufacturing:
6.1
Invasive hence restricted to ISO
13485 subcontractors
Company policy
6.2
Device to be supplied clean in
batches
Standards review
6.3
Sharp edges to be protected
6.4
Finish to be to standard
Standards review
ASTM F86-04
ISO 9714-1:1991
BS 3531-5.5:1990
BS 7254-2:1990
6.5
No animal products to be used in
manufacturing
6.6
Device to be laser marked with CE
mark, dia., company logo, part
number, and lot number.
Standards review
93/42/EC
ASTM F86-04
ASTM F983-86
6.7
Materials restricted by standards
ISO 7153
ASTM F899-09
7 Packaging and Transportation:
7.1
Supplied to end-user as single
items
Initial focus group
7.2
Packaging to protect stab point
7.3
Packaging to protect sharp cutting
edges
7.4
Label to state nonsterile
93/42/EC
CFR21
7.5
Label to state manufacturer's
name, date of packaging, CE
mark, lot number
93/42/EC
CFR 21
BS ISO 15223-2:2010
7.6
Standard package sizes given in
packaging register
Stock package register
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