MDSAP & FDA Certified Medical Device Manufacturing Company
Johari Digital is the leading electronic medical device manufacturer catering to global clients. We design, develop, engineer, and manufacture medical devices for global markets. We are the first MDSAP, US FDA, and GMP audited electronic medical device manufacturing company in India.
We operate from a 65,000 square foot, state-of-art medical device manufacturing facility in India. Johari innovates through its R&D Center in Europe and a Centre Of Excellence in collaboration with IIT Jodhpur. Our services accelerate medical device development and optimize manufacturing costs. Johari’s versatile product development and manufacturing portfolio includes innovative life science products, diagnostic devices, and therapeutic devices.
Delivering value through differentiation
At Johari Digital Healthcare, we ensure innovation-led quality manufacturing at optimal cost with regulatory support, supply chain assistance, and precision across every step of the process.
We pursue manufacturing excellence to produce state of the art medical devices that are precision engineered for achieving: ‘0’ defect / ‘0’ effect (no carbon footprint).
We aspire to be the global leader in healthcare technologies and most trusted partner for medical device development and manufacturing. Medical Device Manufacturers
Authenticity: We believe in being genuine and transparent to our stakeholders.
Extra Step: We believe in taking an extra mile to innovate and succeed.
Customer & Vendor Delight: Flight needs two wings: Delight of customers & Satisfaction of vendors.
Respect: We believe in treating everyone with respect and courtesy.
Quality: We believe in the best quality, best technology and the best product.
Design for Manufacturing
Our DFM team comprising of mechanical, electrical, software and bio-medical engineers is here to help you fully optimize your product for manufacturing. Whether you want to move your prototype into manufacturing, or reduce cost of manufacturing we are here to help.
Our goal is to achieve “0-defects”, we place highest value to close integration, transparency and communication with our clients. Communicating every information with complete transparency helps us maintain long term business relationships and improve efficiency.
Stories Behind People
We are driven to achieve our mission of manufacturing healthcare devices that deliver safe and impactful treatment. Partnering with clients across the globe we have numerous interesting stories to share. To know more about what we do and how we do it explore the blog section.
MDSAP, ISO 13485:2016, US FDA Certified cGMP & 510(k) Certifications
Johari Digital is a leading medical equipment manufacturer with 40+ years of excellence. The manufacturing facility complies with MDSAP, ISO 13485:2016, and FDA (21 CFR 820) standards and processes. We also take special care to protect your intellectual property at every step of the way by following stringent documentation process to maintain credibility.
Product Safety & EMI/EMC
Through our Compliance Group we can guide your product to comply with requirements listed under EMI / EMC & Product Safety Standards. Whether the project is at an early design concept stage, prototyping or manufacturing stage, we readily analyze, test and assist with any required design or component level changes.
Manufacturing Site Inspection
We operate from a 65000 square feet ISO: 13485:2016 compliant manufacturing facility. Regular audits by MDSAP and various global authorities confirm our quality and standards. We also perform GAP analysis & process mapping to continuously evolve our manufacturing services as per changing regulations and standards of quality.
Technical Construction Files
We help our clients in completing documentation requirements related to:
- Technical Write Ups (Instructional Manual, Operator’s Manual etc)
- Product Construction Details
- Engineering information (BOM, Schematics, Cad Drawings, PCB Layouts, Assembly Instructions)
- Software Validation Records
- Device verification Records
- Device validation: This is normally done through the Substantial Equivalence document or by referring to earlier proven clinical studies
Our Driving Force
Founder & Chairman – JDHL
Mr. Satyendra Johari is a technocrat whose passion for work is infectious. He is steering the organization towards a new horizon of global success. This dynamic attitude has propelled him so far in the electronic medical manufacturing business.
Post his B.Tech (Electrical) from BITS-Pilani, he pursued M.S in Economics from West Coast University, USA. Working for 6 years in Medical Device Industry, he returned to India with a clear focus, to start medical device manufacturing in his own country, to encourage the local community.
There were numerous hurdles he had to tackle as the manufacturing landscape for medical devices was not very developed back then. Amalgamating the technical know-how, business acumen, and research aptitude he established an innovation-led MedTech brand catering to global clients.
His exemplary leadership is the key driving force behind the success of Johari Digital Healthcare.
Managing Director – JDHL
An astute business-woman known for her forward thinking. Ms. Nisha Johari is a respected team leader. Steering away from the stereotype, she inspires change aimed at improving productivity and performance at workplace. She played an instrumental role in bringing life to systems and processes across the organization.
One of her remarkable qualities is her ability to understand client’s need and walk the extra mile to give them an engaging brand experience.
She is the official FDA Correspondent of Johari Digital who has spearheaded several products for receiving FDA clearance. She is science graduate from BITS Pilani.
Key Management Personnel
SR. HUMAN RESOURCE BUSINESS PARTNER
DIRECTOR – TECHNOLOGY
DIRECTOR – INTERNATIONAL SALES
How it all began?
The company started with hearing aid production in a 500 sq. ft garage. In 1978, Johari became one of the top three companies in India to produce hearing aids. In 1987 the operations moved to a larger 7200 sq ft manufacturing facility & soon in 1989 Johari became one of the pioneer players to receive US FDA 510k clearance for electrotherapy devices.
As the work and demand for Johari products/services grew, the facility shifted to a 45000 sq. ft manufacturing facility & succeeded in getting ISO 13485 GMP audit in 2005. In a bigger space production boosted and processes became more robust and agile in meeting deadlines, innovating, and grabbing global clients.
In 2019 Johari Medtech was honored with India SME 100 awards. Being a firm dedicated to healthcare device manufacturing Johari aims to become a significant contributor in the mission of making India self-sufficient in healthcare.
In 2021, observing a steady growing demand of global business in MedTech, Johari Digital expanded its facility, adding a sprawling 20,000 sq ft Design & Engineering center. With the expansion, Johari is well-positioned to handle increasing projects in multiple domains of healthcare including life science products, diagnostic devices, and therapeutic devices.
Our inspiring journey is indeed a chronology of proud accomplishments. While every day was a new accomplishment for us, sharing few prominent milestones conquered along the way.
Established in a 500 sq. ft. garage in India and becomes one of only three companies in India manufacturing hearing aids.
Our 7200 square feet manufacturing facility opened for operations.
Became one of the first Indian manufacturers to receive US FDA 510k clearance for an electro-therapy device.
Developed the Torc Plus™ which is the world’s first 8 channel interferential stimulator to receive US FDA 510K clearance.
Relocated to a new state-of-the-art ISO 13485 GMP audited 45000 sq. ft. manufacturing facility.
Received FDA 510k clearance for CES Current.
MoU signed with IIT-Jodhpur to establish Johari’s ‘Incubation and Innovation Centre’.