whaleteq co., ltd* company profile... · we are the 1st test solution provider in the world to...

T h e A ccu ra te a n d C o m p l ia n t T es t S o lu t io n P ro v id er

WhaleTeq Co., LtdCompany Profile and Introduction

© 2017 WhaleTeq All Rights Reserved

We are a professional manufacturer of medical device testing equipment.

Focusing on providing a complete testing solution for medical device

manufacturers.

We are the 1st test solution provider in the world to provide tools that

comply with international medical standards requirements

About WhaleTeq Co., Ltd

WhaleTeq has been working on ECG standard testing

tools and solutions for years, offering test solutions

to leading medical device manufacturers and test

labs from over 30 countries.


Global Customers400+ Customers Worldwide

Since 2013, more than 400 clients from 31 countries, whose domains include

healthcare equipment manufacturer, OBMs and related certification laboratories,

have adopted test solutions from WhaleTeq.


Medical DeviceManufacturer

Consumer Electronic Manufacturer

Laboratory

Worldwide Customers Categories


WhaleTeq Worldwide No.1s

◼ (2014) The 1st ECG/EKG Test System compliance with international medical standards

◼ (2016) The 1st PPG optical heart rate simulator for wearable device

◼ (2018) The 1st multifunction wearable device performance tester

◼ (2019) The major drafter of 1st wearable ECG/PPG testing standard released in Shenzhen China

2014 2016 2018 2019


Indispensable Test Equipment

Cloud

Big Data + ML/AI

Digital HealthPreventive Medicine

Smart glasses

Smart earphones

Smart cloth

Heart beat monitor band

Smart bracelet

Smartwatch

Smart ring

Smart socks

Smart shoes

Reliability Accuracy Compliance Essentials of Test Equipment

Whaleteq all rights resvered

Verification & Validation

Regulation Requirements

Essential PerformanceFunction, Accuracy, Stability, …etc.

IEC60601-2-xxISO80601-2-xx

AAMI, ANSI, CEN, IEC, ISO………

SterilizationISO11737…

Radiation SafetyIEC60601-1-3

Microbiologic, Chemical, etc..

Electrical SafetyIEC60601-1

EMCIEC60601-1-2

Risk Management

ISO14971 SW ValidationIEC62304

Labeling requirements

Clinical investigationISO14155

etc.

UsabilityIEC62366

Verification&

Validation

Quality SystemISO13485

BiocompatibilityISO10993

AlarmsIEC60601-1-8

Home HealthcareIEC60601-1-11

Professional Simulator

WHALETEQ Regulation & Verification

SOLUTION

Regulation Threshold

Regulation Services

Regulation BarrierThe Pain Points of Medical Device Company


Medical Device Quality Control

8

R&D Management Procedures

HW Verify (Filter、Amp、ADC…)

SW Verify (Function、Reliability…)

Algorithm Verify (Accuracy…)

Specification Verify

Risk Management

SW Validation

Usability

System Validation

Verification & Validation Test

Safety Test (60601-1, -1-2, -2-

xx …)

Production/QC

Purchase

IQC

Assembly

Testing

QUALITY SYSTEM

ISO13485

Management Process – Plan, Do, Check, Act


Importance of Test PlanDecrease Clinical Trial Expense and Reduce Time to Market

GMP / ISO13485

V & VClinical

TrialRegulation Submission

ManufacturingR & D

WhaleTeq R&DTest Solutions

Compliance

Medical Device Requires Extensive Testing

AccuracyReliability

WhaleTeqProduction

Test Solutions


Vital-sign Simulators and Software

Heart Rate

ECG/PPG Heart Rate Simulator

Blood Pressure

Statistic Pressure Tester

Dynamic Pressure Tester

SpO2 Level

Transmissive Type Tester

Reflective Type Tester

ECG/EKG

Multi-lead ECG and Heart Disease

Simulation System

Algorithm Verification Software for

Rhythm Databases

Respiration

Resistance Type Simulator

Respiration Tester

RA

LL

LA

RL/N

EEG

EEG Simulator

EEG Database Tester

Temperature

Contact Temperature Test System

Infrared Temperature Test System


Product Strategy

Application Product Lines

Vital Signs Monitoring

ECG, Blood Pressure, EEG, SpO2, Temperature

Blood Glucose, Respiration

Home Health Care

WearableMobile Health Care

HR, Blood Pressure, SpO2

Cover Both Medical and Healthcare Applications


WhaleTeq Simulator and Analyzer

SpO2

NIBP

ECG/EKG

✓ AECG100-R

✓ AECG100-T

Accurate and Compliant

Wearable Device

EEG

PPG

✓ SEEG100

✓ BPA100

✓ SECG 4.0

✓ MECG 2.0

✓ CMRR 3.0+

✓ SECG 5.0 AIO

✓ HRS200

✓ HRS100+

✓ AECG100


WhaleTeq Software

ECG Algorithm Analysis Software

✓ CTS/CSE Database Comparison

✓ PhysioNet/AHA Database Analysis

Production Line Testing

✓ Auto/Semi-auto Testing Line Design

✓ Test Flow Design

✓ Test Data Collection and Analysis

✓ System Validation Report

✓ Compliance with ISO13485 3rd Ed.

Requirements

Exclusive Design to Increase Efficiency


Pre-testing and Training Service

Training Course

Pre-testing and Report

Algorithm Pre-testing and Report

✓ Performance pre-test and report

✓ Safety & particular standard pre-test and report

✓ IEC60601-2-xx standards

✓ Algorithm tests

✓ Regulation requirements for FDA, CE…etc,

✓ Diagnosis ECG Algorithm Test Service

✓ Portable ECG Algorithm Test Service

✓ Clinical ECG Database (WhaleMED Cloud)


Test Recommendations

Application&

Customer Type

RD RD RD/QA Safety / RA QC Production After Service

Hardware/ Firmware

AlgorithmSystem

ValidationCompliance

TestIQC / OQC

System/ Semi-finished Goods

CustomerSupport

ODM ●●■

▲●■

● ▲ ●

OEM ● ▲ ●

Solution Designer ●●■

▲●■

●

Brand Owner ●●■

▲●■

● ▲ ●

Algorithm Developer

●■

▲●■

●

For the Supply Chain of Medical Device

● Test Equipment & Software ■ Pre-Test Service▲ Test System


Product & Service Map

• ECG Algorithm Test Service

• Test Plan Design

•FDA

•CE

•TFDA

•CFDA

• RD & QA V&V Solution

• Production Test Automation

• Report Generator SW

• ECG

• Wearable

• SpO2

• NIBP

• EEGSimulator

&

Compliance Software

Test system

&

Report Generator

Test Service

&

V&V Plan

Regulation Consultancy

16


Contact Us

[email protected]

www.whaleteq.com

We Simplify and Explain the Procedures to Save Your Time !!

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