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Medical Device Technology Capabilities in India
- 2. 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
- 3. Advantages of Partnering with Johari Johari Digital Healthcare Ltd.
- 4. 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
- 5. Advantages of Partnering with JOHARI • 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
- 6. Advantages of Partnering with JOHARI • 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
- 7. Advantages of Partnering with JOHARI Turn Key Solutions, Services and Options. Turn Key Solution
- 8. Production and Manufacturing facility Johari Digital Healthcare Ltd.
- 9. Manufacturing Facility Our State-of-the-art manufacturing facility : small, medium, large volume production, from simple to complex electronic medical devices. Spread Over 45,000 Sq. Ft.
- 10. Electronic Manufacturing Service With class 100,000 clean rooms, and fully automated manufacturing lines
- 11. Mechanical Assembly Services Comprehensive 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
- 12. Medical Device Packaging Services Aspects of Packaging Services Medical: Ensuring quality and performance of your medical packaging Regulatory : Making sure that your packaging meets and exceeds regulatory requirements. Environmental : Ensuring your products and packaging perform in harsh environmental conditions Distribution : 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.
- 13. Design and Development Services Johari Digital Healthcare Ltd.
- 14. 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
- 15. Medical Technology Development CenterElectrochemistry Potentiometric, Amperometric, Conductive. LIBS – Laser-Induced Breakdown Spectroscopy, Photoacoustic Spectroscopy of Gases Photoacoustic Spectroscopy of Solids Absorption Spectroscopy (VIS, NIR, Mid-IR) Lasers: Nd:YAG, Nd:glass, CO2, Ar+, laser diodes, optically pumped semiconductor lasers), LED, Gas lamps. Ultrasound Systems High-Resolution CORE TECHNOLOGY GROUP GUI Applications Development through PhotoShop Software Application Design Based on ARM processor and Windows CE Operating System Injection Moulding , Solid Works Designing Software System Design, Embedded and Desktop GUI Applications Design and Database Design. Embedded GUI application design using .NET Compact framework 2.0 Desktop GUI Application Design Using C# Language and .NET framework. SOFTWARE/ INDUSTRIAL MECHANICAL TEAM CAPABILITIES Real-Time Embedded Systems Design FPGA/ASIC design Analog and Digital Electronics, Microprocessors and Microcontrollers, RF &RFID technology Power Management Data Acquisition Systems User-Centric Industrial Design INSTRUMENT DEVELOPMENT • Committed for Innovation and new technologies • Proudly Recognized DSIR, Government of India. (Department of Scientific Industrial and Research)
- 16. 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
- 17. Mechanical Engineering Services In-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
- 18. Industrial Designing From 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.
- 19. Quality Assurance and Compliance Service Johari Digital Healthcare Ltd.
- 20. At Johari Digital we are very passionate about Medical Device Regulatory and Quality standards and requirements. Regulatory and Quality Standards FDA and ISO Standards ISO9001:2008&ISO 13485:2003 • 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,510K • 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 FDAQualitySystem Regulations • Johari Digital has a FDA approved Quality Management System in place. Good Manufacturing Practices are being followed in all the manufacturing procedures and activities.
- 21. Regulatory and Quality Standards Testing 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. IEC60601 • 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 EMCDirective • 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.
- 22. Globally Regulatory Certifications Internationally Certified US FDA Audited GMP “Goods Manufacturing Practice” & ISO 13485 US FDA 510(k) CMDCAS : Health Canada CE, UL, TGA
- 23. 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
- 24. Success Stories and Global Customer Base Johari Digital Healthcare Ltd.
- 26. 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. Robinson Vice President Operational Strategic Planning Boston Scientific
- 27. Medical Aesthetic - Face Lifting Partner’s Product Launch
- 28. Partner’s Product Launch Spectrometer Bio-Diesel Analysis
- 29. Partner’s Product Launch Home HealthCare Blood Pressure, Temperature & Pulse oximeter Monitoring
- 30. Partner’s Product Launch Home Healthcare Facial Rejuvenation
- 31. Partner’s Product Launch Scientific Laboratory DNA/RNA Extraction
- 32. Partner’s Product Launch Home Healthcare Relaxation and Anti-Stress
- 33. Partner’s Product Launch Medical Aesthetic LASER Based Hairgrowth
- 34. Partner’s Product Launch Medical Aesthetic Body Toning and Contouring
- 40. Find Us Globally Corporate Office : G-582-584, EPIP, Boranada, Jodhpur (Rajasthan), India Branch Office – Mumbai : 206, 2nd Floor, New India Industrial Estate, Off Mahakali Caves Road, Andheri East, Mumbai – 400093, India Worldwide Distribution – USA 5858 Dryden Pl, Suite# 201, Carlsbad, CA, 92008 Our Global Presence Johari Digital Healthcare Ltd.