Medical Device Technology Capabilities in India

Medical Technology Contract ManufacturingElectro Medical Devices

WHAT WE DO ?

▪ Design & Research Service▪ Industrial Design and Research▪ Mechanical Design▪ Concept to Prototyping▪ Regulatory Compliance▪ Electronic Manufacturing▪ Medical Device Assembly▪ Packaging & Branding▪ Small / Mid / High Volume Production

38 Years of Medical Technology Research & Contract Manufacturing. 56 Commercialized Products.48 Happy Partners.One Love for what we do

Advantages of Partnering with JohariJohari Digital Healthcare Ltd.

Advantages of Partnering with JOHARI

• We Value your time and budget!• Reduce up-front investment, mitigate

outsourcing risks, and see clear and measurable impact on your final goals and bottom line.

Fully Engaged & Flexible Product Development Partnership


• Avoid stress of managing never-ending projects.

• Get guarantees and assurance on the timelines & deliverables, and create healthy environment by supporting a mutual goal – commercially successful biomedical instrument.

Results Based Engagement


• Johari has developed unique processes, capabilities and disciplines to effectively address challenges of working with highly complex nature of life science and diagnostics biomedical instrumentation.

• Improve your Bottom Line...

Reduced Total Cost of Ownership

Advantages of Partnering with JOHARITurn Key Solutions, Services and Options.

Turn Key Solution

Production andManufacturing facilityJohari Digital Healthcare Ltd.

Manufacturing FacilityOur State-of-the-art manufacturing facility : small, medium, large volume production, from simple to complex electronic medical devices.Spread Over 45,000 Sq. Ft.

Electronic Manufacturing ServiceWith class 100,000 clean rooms, and fully automated manufacturing lines

Mechanical Assembly ServicesComprehensive High and Low Volume Mechanical Assembly services

Our expertise includes▪ Electrical and Mechanical Assembly Systems▪ Manual and Box-build Assembly▪ Basic Hardware Installation▪ Component sub-assembly complete

mechanical assembly from multi- layer BOMs▪ Electrical Circuit Board Assembly▪ Plastic Assembly▪ Product testing and inspection▪ Packaging Assembly▪ Repair, rework, and inspection capabilities

Medical Device Packaging ServicesAspects of Packaging ServicesMedical: Ensuring quality and performance of your medical packagingRegulatory : Making sure that your packaging meets and exceeds regulatory requirements.Environmental : Ensuring your products and packaging perform in harsh environmental conditionsDistribution : Ensuring safe and reliable transport of your product packaging

Johari Digital’s packaging services provides a strategic element in your company’s product design, profitability and overall market success. With state-of-the-art testing equipment designed specifically for delicate goods and medical packaging, Johari Digital is the experienced resource you can count on to help you safeguard your product and deliver the reliability you expect.

Having a detailed understanding of how to best design and manage the performance of your products and packaging helps you stay ahead of your competition.

Design and Development ServicesJohari Digital Healthcare Ltd.

Medical Core Technology Research

Electrotherapy,

Ultrasound, Therapeutic

LASER

Electro Chemistry Analyzer –

Blood Sample Test

Photo Density Analysis –

Optical Based System

High Speed Motor Driver

– DNA Sample

Preparation

Talking Devices For

Visually Challenged

Physio

Medical Technology Development CenterElectrochemistry

Potentiometric, Amperometric, Conductive.LIBS – Laser-Induced Breakdown Spectroscopy, Photoacoustic Spectroscopy of GasesPhotoacoustic Spectroscopy of SolidsAbsorption Spectroscopy (VIS, NIR, Mid-IR)Lasers: Nd:YAG, Nd:glass, CO2, Ar+, laser diodes, optically pumped semiconductor lasers), LED, Gas lamps.Ultrasound SystemsHigh-Resolution Imaging

CORE TECHNOLOGY

GROUP

GUI Applications Development through PhotoShop Software Application Design Based on ARM processor and Windows CE Operating SystemInjection Moulding , Solid Works DesigningSoftware System Design, Embedded and Desktop GUI Applications Design and Database Design.Embedded GUI application design using .NET Compact framework 2.0Desktop GUI Application Design Using C# Language and .NET framework.

SOFTWARE/ INDUSTRIAL MECHANICAL

TEAM CAPABILITIES

Real-Time Embedded Systems DesignFPGA/ASIC designAnalog and Digital Electronics, Microprocessors and Microcontrollers, RF &RFID technologyPower ManagementData Acquisition SystemsUser-Centric Industrial Design

INSTRUMENT DEVELOPMENT

• Committed for Innovation and new technologies

• Proudly Recognized DSIR, Government of India. (Department of Scientific Industrial and Research)

Electronic Design Services• 30 years of experience in

Electronic Design Development

• Design of complex electronic products integrating FPGAs, DSPs, Analog/Power, RF, microprocessors, and other cutting-edge technologies.

• Multi Layered PCB design/layout

• Microprocessor, FPGA, Touch Screen user interface

Mechanical Engineering ServicesIn-house Facility• Lathe M/c • Milling M/c• Vertical Drilling• Grinders• Injection Molding (Small

Parts )

Johari Digital Provides In-House Mechanical Engineering Services▪ Design development, tooling and molding of

housing, case enclosure▪ Tolerance & Dimensional Analysis▪ Mechanism Synthesis▪ Plastic Injection Molding▪ CNC machined components parts▪ Drop, Shock and Environmental Considerations▪ Thermal Analysis▪ EMI & ESD Solutions▪ Tooling

Industrial DesigningFrom concept sketches to design & development, we care to add artistic flavors to your device. In due process we carefully evaluate functional and regulatory requirements, human factors & user experience.

Quality Assurance and Compliance ServiceJohari Digital Healthcare Ltd.

At Johari Digital we are very passionate about Medical Device Regulatory and Quality standards and requirements.

Regulatory and Quality StandardsFDA and ISO Standards

ISO

900

1:20

08

& IS

O

1348

5:20

03• Johari Digital Healthcare Ltd acquired ISO 9001:2008 certificate in the year 2010. ISO13485 processes have been built into every stage of our manufacturing and quality assurance functions.

US.

FDA

, 510

K• We have to date

received FDA clearance for all of our devices under medical devices Class I, II & III. Every FDA submission is completely prepared in house by our experienced team

FDA

Qua

lity

Syst

em

Regu

lati

ons

• Johari Digital has a FDA approved Quality Management System in place. Good Manufacturing Practices are being followed in all the manufacturing procedures and activities.

Regulatory and Quality StandardsTesting Standards

UL

/ CE • Johari Digital

Healthcare Ltd acquired ISO 9001:2008 certificate in the year 2010. ISO13485 processes have been built into every stage of our manufacturing and quality assurance functions.

IEC

6060

1• We have to date

received FDA clearance for all of our devices under medical devices Class I, II & III. Every FDA submission is completely prepared in house by our experienced team

EMC

Dir

ecti

ve• Johari Digital has a FDA approved Quality Management System in place. Good Manufacturing Practices are being followed in all the manufacturing procedures and activities.

At Johari Digital we are very passionate about Medical Device Regulatory and Quality standards and requirements.

Globally Regulatory CertificationsInternationally Certified

US FDA Audited GMP“Goods Manufacturing Practice”

& ISO 13485

US FDA 510(k)CMDCAS : Health Canada

CE, UL, TGA

Regulatory & Quality Services

▪ Product Development and Commercialization Strategy

▪ Regulatory Classifications, Applications and Submissions

▪ 510(K), PMA, Health Canada License, CE marking

▪ Labeling▪ Risk Management

Quality Systems (QSR, ISO 13485)▪ Assist in conducting Audits▪ Validation Solutions▪ Post Marketing Regulatory Services

Risk

Identify & Analyze

Examine

SelectImplement

Monitor Result

Success Stories andGlobal Customer BaseJohari Digital Healthcare Ltd.

Global OEM Partners

Customer Visit & Testimonial

“We're very pleased with the impressions of JDHL and its Manufacturing facility in Jodhpur.

We were impressed with the level of understanding of Medical Device manufacturing practices, and particularly their openness to learn best practices from others (including the FDA),

Overall, a very successful visit.”Donald E. RobinsonVice PresidentOperational Strategic PlanningBoston Scientific

Medical Aesthetic- Face Lifting

Partner’s Product Launch


SpectrometerBio-Diesel Analysis


Home HealthCareBlood Pressure,

Temperature & Pulse oximeter Monitoring


Home HealthcareFacial Rejuvenation


Scientific Laboratory DNA/RNA Extraction


Home HealthcareRelaxation and Anti-Stress


Medical AestheticLASER Based Hairgrowth


Medical AestheticBody Toning and

Contouring


Winstim


HiMedia


Stimtec


IF-5000


Max-90

Find Us GloballyCorporate Office : G-582-584, EPIP, Boranada, Jodhpur (Rajasthan), IndiaBranch Office – Mumbai : 206, 2nd Floor, New India Industrial Estate, Off Mahakali Caves Road, Andheri East, Mumbai – 400093, IndiaWorldwide Distribution – USA5858 Dryden Pl, Suite# 201, Carlsbad, CA, 92008

Our Global Presence

Johari Digital Healthcare Ltd.

Business

Medical Device Technology Capabilities in India