Certification Assurance

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

MedelaBottle Sterilizer and Warmer

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