1. Signed & Approved by
CEO- Vinie Varkie
General Manager- Shrishti Jain.
Chief Business Strategist- Igwe Daniels
Chief Scientific Officer- Helena Gwani
Operating Manager- Priyesh Waghmare
Marketing Manager- Ayo Awosusi.

2. Content
o Introduction
o Company Profile
o Salary Distribution
o Gantt Chart
o Quality Control
o IP status
o Internal Management Systems policy
o Registration for ISO 13485 Now is the
o CE marking 7rocess future… lol.

3. Introduction
Pre- Eclampsia
Globally, Causes: Symptoms:
•10% of all •Damage to the blood •Rising High blood
pregnancies vessels pressure
•Insufficient blood flow •High protein levels in
•12% of maternal
to the uterus the urine
deaths
•Severe headache
•1/3rd of pre mature
births •Visual Disturbances
G7 DIAGNOSTICS

4. Market need
12% of maternal deaths Global prevalence of pre-eclampsia
Our market research reveals:
There is no clinically useful screening test to predict the
development of preeclampsia in either low-risk or high-
risk populations.
G7 DIAGNOSTICS

5. Company profile
Research and Operations Business Administration and Quality Systems
Development (Process Development Finance •Quality
Development) Assurance
•Chief Scientific •Chief Executive engineer
Officer •Scientists (PhD,
•Market Officer
B.Sc) Research analyst •Quality Control
•Scientists (PhD, •Finance Manager engineer
B.Sc) •General Manager •Business
development •Documentation
•Assistant analyst specialist
•Validation
engineer

6. Salary Distribution (pre-clinical trials)
Role Number Work Status Salary (GBP p.a.)
1.Development
Chief Scientific Officer 1 1 day/ week 15,000
Scientists (PhD) 2 Full-time 30,000
2. Operations (Process Development)
Scientists (PhD) same as above _ _
Scientists (B.Sc) 1 Full-time 25,000
General Manager 1 Full-time 60,000
3. Business Development
Business Development analyst 1 2 days/ week 30,000
Market Research analyst 1 2days/ week 12,000
4. Administration and Finance
Chief Executive Officer 1 1 day/week 18,000
Finance Manager 1 1 day/week 12,000
5. Quality Systems
Quality Assurance engineer Scientist (B.Sc.) _ _
Quality Control engineer 1 1 day/ week 17,500
Documentation specialist 1 1 day/ week 12,500
Validation engineer 1 1 day/ week 15,000

7. PRODUCT DEVELOPMENT - GANTT CHART
20-Jan-11 11-Mar-11 30-Apr-11 19-Jun-11 08-Aug-11 27-Sep-11 16-Nov-11 05-Jan-12
Planning 30
Manufacturing
Specification 30
Process design 60
Product design 60
Production of 2040 strips 30
Production of 50 meters 30
Quality Control
Verification 20
Validation 30
Feedback 30
Legal 365
File Patent PCT

8. Development phase: Gantt chart
S.No. Tasks Start Date Duration (days) End Date Cost involved
(£'000)
1 Planning 20/01/2011 30 19/02/2011 10
2 Manufacturing
Specification 20/02/2011 30 22/03/2011
350
Process design 23/03/2011 60 22/05/2011
Product design 23/05/2011 60 22/07/2011 86
Production of 2040 strips 13/10/2011 30 12/11/2011 51
Production of 50 meters 13/11/2011 30 13/12/2011 400
3 Quality Control
Verification 22/07/2011 20 11/08/2011
Validation 12/08/2011 30 11/09/2011 80
Feedback 12/09/2011 30 12/10/2011
4 Legal 20/01/2011 365 20/01/2012 80
filing a patent
licencing
liability
therapeutical consequences
reliability of results
5 Salary 247
G7 Total 1,304

9. Gantt chart
• The research phase is not
considered
• Production of equipment and
strips subcontracted
• The respective subcontractors
follow standard procedures and are
ISO13485 registered
G7 DIAGNOSTICS

10. Quality Control System
(Validation and Verification)
Selectivity 95%
Being
spot-on
Specificity 95%
at
Reproducibility 91%
quality
is
Storage conditions 20°C
always
an issue
Heat stability 15°C – 30°C at G7…
G7 DIAGNOSTICS.COM

11. IP Status
Patent No. Title Inventor Applicant
GB 2464222 Analysis method and Bolbot, J. A. Inverness Medical
device. (2010) Switzerland Gmbh
EP 1175940 Diagnostic devices Beuchler, K. Biosite Diagnostics Inc.
and apparatus for the A. (2002)
controlled movement
of reagents without
membranes.
G7 DIAGNOSTICS.COM

12. G7 Diagnostics internal management system policy
“…policy shows the commitment of the company as it
encompasses quality, environmental management and
safety measures which the company holds in high
esteem.”

13. Registration for ISO 13485
Review of Internal Quality Management system policy
Hold meetings within Quality System team:
• Objectives of ISO 13485
• Medical Device regulations
• Coach members across functional departments
Conduct internal audits and spot checks
Audit by (external) notified body

14. CE Marking Process
Full quality assurance system
G7 pre-Eclampsia (Annex II)
strip and meter The notifying body will assess
and monitor our quality system
“ … acquisition of the CE Marking is very important in
boosting our chances of increasing sales especially
considering the stringent rules by which hospitals (our
target market) operates…”

15. Technical file
• Intended use of the test: early
detection of pre-eclempsia
• Indication for use: Week 12 and
week 19 of gestation period

16. Quality Management Systems certification
Product Classification: Annex II List B (non-self
testing)
Declaration of conformity (Annex III)
Aiming at European Market Acceptance:
– ISO 13485
– CE marking

17. Technical file: Equipment specification
1- Power Button
2- LCD (liquid crystal display)
3- Thermal Printer
4- Printer Cover
5- Diagnostic Device Insertion Point
6- Power Supply Connection
7- Data Connection
8- Printer
9- Battery Cover
10- Code Chip Port

18. Meter specifications
Physical
Size Diameter 8.5" , Weight 6.25", Height 2.75"
1.5 pounds without batteries; 1.6 lbs with
Weight batteries
Keypad 12 numeric keys, 10 function keys
Environmental
6 volt DC @ 1 amp.
Electrical
Temp 15 C - 30 C
AC / DC converter or 4 AA batteries
Printer Humidity
Panasonic Thermal Printer 85%
10% -
Optical
Interface RS-232 Computer Serial Port
Laser Laser Diode - 1 milliwatt
Detector Silicone Photodiode
Location Dry, flat, horizontal surface away from direct sunlight
Memory capacity
User ID's 600
Patient Diagnostics 750

19. Technical file: Strip specification
ZONES SPECIFICATIONS
Main Body Plastic material: length 10cm, width 3cm.
1
1. Sample addition zone Round shape
2
•Open trough.
3 2. Sample addition Reservoir •Filter – PA 66, Polyamide ( mesh count: 93mesh/inch, diameter 0.10nm,
thickness 0.18mm).
4
5 3. Sample-reaction barrier •Narrow capillary: diameter 0.05mm
•Depth 5mm, width 0.3mm.
6 4. Reaction chamber
•Nanoparticle based antibody with fluorophore: powder 1.4nm,
fluorophore: Alexa488.
5. Time gate •Polystyrene latex: diameter 2µm, length 1mm.
•Binding component: Bovine serum albumin.
7
6. Fluid control means
•Trapezoid shaped gap.
7. Diagnostic element •Two opposing surfaces a capillary distance apart
•Antibodies array:
•Soluble fms-like tyrosine kinase (sflt)
•Soluble Endoglin (sEng)
•Placental growth factor (PlGF) antibodies.
8. Used reagent reservoir •. •Nitrocellulose material.
8 •Capillary space: width 2mm, depth 1mm.
•Capillary grooves: depth 0.3mm, density 40 grooves/cm

20. Risk management
•Careful sample
collection, labeling
and storage
•Storage of strips at
YES What necessary proper temperature Implementation
steps to be taken •Periodic (monthly) of corrective
to minimize risk? calibration of meter actions
•Bar code
Will the end user be harmed validation
at any point?
Continue
monitoring
NO

21. Summary:
• Detailed description of Gantt Chart
• Time period for Product development estimated as
~ 1 year
• Conclusion:
• Long term vision- G7 as global company
• Immediate goal: to attain the ISO 13485 and
fulfill regulatory requirements

22. THANK YOU
FOR
LISTENING
a G7 Diagnostics Inc. Production.