certification assurance
TRANSCRIPT
Medical devices since 1988
Company Profile• Established in 1988 as the
leading medical device contract manufacturer.
• Total of 1300 employees in 8 factories acros 5 countries.
• Product design, prototyping, soft tool, PCBA, sub-assembly, production and full turn-key.
• Class 100K/ISO 8 Cleanroom assembly & moulding.
• Process qualification and validation capabilities.
• Product certification.
USA, San Francisco
Racer Technology Inc.
USA, California India, Chenai
India, Chenai
Racer Technology India
SingaporeHeadquarters
Singapore’s 2nd Factory
Singapore
Racer Technology Pte Ltd (HQ)
Indonesia, BatamIndonesia
4th FactoryIndonesia
3rd FactoryIndonesia
2nd Factory
Indonesia, Batam
PT Racer
Malaysia, Senai
Malaysia, Senai
Racer Technology Sdn Bhd
iTechnik Precision Sdn Bhd
Seii Manufacturing Sdn Bhd
Medical devices since 1988
Certification Assurance• ISO 9001:2015 Quality Management System
• ISO 13485:2016 Medical Device
• ISO 14001:2015 Environmental Management
• ISO 17712:2013 Security Product/Device
• FDA Registered Facility, Medical Product/Device
• Product Safety Mark Certification
• EU Medical Device Directive 2007/47/EC
• International Standard (VDE, BS, etc.)
• Third Party Standard (AAMI, ASTM, ANSI, etc.)
• Safety and Conformity Marks (CE, UL, CCC, etc.)
Land Area: 719 sq. km
Population: 5.54 million, extremely cosmopolitan where about
one-third is non-Singaporean
2016 GDP: S$410 billion (approx. USD 294billion)
Per Capita GDP: S$ 73,000 (approx. USD 52,000) –Highest inAsia
Quick Figures
The easiest place to do business globally 1st in Ease of Doing Business, World Bank1
Asia’s best intellectual property protection 1st in Asia, World Economic Forum2
Most transparent country (for business related policies) globally
1st in Asia, World Economic Forum2
Investing & Doing Business in Singapore
1World Bank Group’s Doing Business 2015 Report2World Economic Forum’s Global Competitiveness Report 2015/2016
About Singapore
Medical devices since 1988
1. Stable policy &
regulatoryclimate
• Strong IP protectionlaws
• Business-friendlyregulatory
climate
• Political stability
3. VibrantMedTech
ecosystem
• Concentration ofservices that
fully support MedTech
manufacturing
• Thriving ecosystem of high-
technology researchactivities,
tech start-ups and investors
2.Business-friendly
environment
• Easy access to a
predominantly English-
speaking skilledworkforce
• Excellent developed
infrastructure forbusiness
operations
4. Launchpad intoAsia
• Asia’smost extensivenetwork of FTA,covering 60% of the world’sGDP
• Medical devices registered with the Health Sciences Authority (HSA) in Singapore can enjoy expedited regulatory approvals
in all 10countries inASEAN
• ExcellentASEAN–Asiatrade conditions: with China, India,JapanandKorea
• UsingSingaporeas abaseto bridge the significant differences between the medical worlds inAsiaand theWest
4.World-class
connectivity
• Regional hub for top global
logistics firms
• Hometo the world’s busiest
transshipment sea port and
one of Asia’s largest cargo
airports
Singapore’s value proposition for theMedTech industry in the region
Singapore isAsia’s choice location forcompanies seeking a manufacturing &
logisticshub
$11Bmedtech
manufacturing output
in 2016
>30medtech MNCs have regional
HQ inSingapore
World-class connectivity & Asia’s
most extensive network of FTA,
covering 60% of the world’s GDP
>25medtech MNCs have set upR&D
centres
>30medtech MNCs
have set up manufacturing
plants
Singapore is 1 of the 3 TAA (Trade Agreements Act) designated countries
in the ASEAN region. Sourcing from TAA compliant countries is required
when supplying products to the US government organisations, such as
veteranhospitals
Ingress Protection ~ IP 54
(Dust Tight)
WearablesLow Pressure Mould
~ IP 67 (Immersion)
Dragger Medical
Product PortfolioDesign
Security Seal
Mini Mouse Nano
Cochlear ImplantHead Piece
Breast Pump
HIV test kit for 3rd world countries
HIV Test KitCambridge University
Production run of 2 million unitsDesign Development
Prototype Testing
BULLGUARDDojo Internet Security Device
Pebble 3D construction
FUEL3DHandheld 3D Imaging Scanner
Wafer Blade
TOTAL CONTAINMENT DEVICEMedical Equipment (USA, Boston)
Blade & arm
Main PCBA Power Unit PCBA
Ethernet Port/E1
Touch Screen
Lid handle has a surface
area of 16mm for gripping
LCD resistive
touch screen with
PET 4”in”
Hinge feature moulded on
the lid. Reducing the
number of parts.
The entire arm socket unit
is now a single block
which gives an advantage
for adjustments during
installation.
Cutter
Standard USB portPower switch.
-Can be made in a different material.
Plasma Blood RF Sealer
Assembly
GENESISOmni
Input/Output
Clamp
2 Prototype units
Production 10-20 units/mth
CLEARBRIDGEClearCell® FX1 System
Handheld multiplex point of care
diagnostic for differentiation of
Lassa fever, Dengue fever and Ebola
Hemorrhagic Fever
Microfluidic
Monthly labour cost (8 hr/day, 44 hr/week)
-China, USD$480
-Malaysia, USD$380
-Batam, USD$320
-Singapore USD$650
Auto Haematology Analyser
• Fully-flexible 4.6mm diameter LED
light strip
• Freely bendable and can be safely
placed deep inside the open
surgical cavity
• One-time use disposable
• 4-hour lifespan
Vivo SurgicalSurgical LED Light
Konica MinoltaWoundAid Camera
Wound measuring device to
measure size and depth and
record wound recovery
progress.
RenewMedical Heart Assist Circulation Instrument ~ NCP 4 ~
SK-IIMagnetic Booster
2nd launch in all
major airports
Soft launch in China
Japan launch in 2015, backorder of 2 mil
AwardsVOGUE BEAUTY
AWARDS 2017
Reader’s Choice Gold & Break Through Bronze
Osaka P&G Innovative Awards
Counterfeit Original
Counterfeit Original Counterfeit Original
Black MarketPrice Increase
Vapore Ilc
Fitbit
Concept 1: Personal TrackerSingle button function
Concept 2: Personal TrackerClip Concept
Founded and Led by
Reagent Handling and Packaging
We offer manufacturing of sterile finish dosage regent
in our filling & compounding in our facility in Changi,
Singapore. Our facility was commissioned in March
2018. It consist of complete manufacturing records &
analysis of lot produced with regulatory test
documentation, follow by labelling and packaging
specified dosage (5ml to 100ml) in glass and vial
bottles.
Diluent Bag SealingUV CuringChemical Powder Weighing
SEII Sub-Assembly Lines