2023 Exhibition
(including all MDI partners)
MDI Expo 2023 includes a large expo area, where products and services will be introduced. Make sure to visit, network, and learn about all the news in the medical devices and digital healthcare community
Founded in 1983, Advantech is a leader in providing trusted, innovative products, services, and solutions.
With decades of proven experience, Advantech is a leading player in the global healthcare market.
Advantech iHealthcare has developed its core competencies and collaborated with international medical equipment manufacturers and system integrators, to assist hospitals with advancing patient-centered healthcare.
A.J Englander 1980 Ltd. has been managing an outsourcing-outsourcing system for various companies in the field of metal and plastics, electronics, optics and electro-optics for medical, house hold and food industries.
The company’s experience is focused on allocating resources to the following areas: raw materials and hard materials. Cutting tools, optics, plastics, motion systems, motors, FIBRO standards for molds and dies.
Almond Is a professional eQMS That was Developed by Gsap. Our Unique Quality Management Software Computerizes The Quality Process While Ensuring Compliance With Regulatory Requirements. Almond Was Established Based On The Vast Knowledge Gained From Years Of Experience Consulting And Accompanying all types of healthcare companies, from small Startups to Large corporations.
arazim Ltd. Is leading suppliers of SENSORS and related instrumentation for the local hi-tech industry, mainly for the Defense & Medical markets.
Promoting world-wide leaders at these field we offer wide range sensors for static and dynamic analysis, Microphones & Speakers, Magnetic sensors & switches, Zero-Power Motion switches, Pressure & Flow sensors, Micro-Camera for Medical Endoscope, Miniature Encoders, Shock & Vibration sensors, Inertial Sensors, Ultra Low-Power MEMS & ASIC's and many more.
arazim provides also design services for the Medical Industry.
Our expertise includes Ultra-Low-Power, Miniature Embedded Systems (HW/SW) , Sensor Systems , dedicated algorithms and many more.
We do provide full complete solution, from concept to prototype to production to FDA approval.
arazim is ISO-9001-2015 Certified.
ArtCybe is a one-stop-shop for medical device development. We specialize in multidisciplinary projects from concept to mass production. The ArtCybe experienced team offers world-class services in the fields of engineering, product design, regulation, bioinformatics and data analysis, clinical trials, and intellectual property protection. We provide our services as a boutique design house to seed-stage startups and billion-dollar companies alike. Together, we can make your idea a reality.
Atena is a global manufacturing company offering a wide range of turnkey solutions. Providing integration, cabling, wiring and mechanical assemblies, in addition to NPI solutions that include automatic mechanization for electronic card assembly (PCBA), Atena works together with its customers to implement, optimize, and achieve their goals.
Atena adheres to the highest industry standards and is committed to high-quality solutions at low shipping costs. A subsidiary of IMCO Industries, an organization in full compliance with medical standards: ISO 13485:2016, ISO 7 Cleanroom, and quality management system standards ISO 9001:2015, FDA, Atena is a leader in advanced manufacturing capabilities, both in Israel and the US.
Design and manufacture of shaped pacakges, dedicated packaging for a variety of applications in thermoforming technology, vacuum forming and plastic injection in clean rooms. Performing mechanical assemblies and closing packages in clean rooms.
Conlog is active in consulting, engineering and marketing since 1972 for a wide range of industries, specializes in the following areas: Automation & Pneumatics, Mechanics, Motion & Control, and engineering solutions.
Conlog provides capabilities to produce creative engineering solutions, and assembly according to customer design.
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REPRESENTATIVES
IGUS CPC PISCO KOGANEI BHAR HIWIN ,QOSINA,TFS(TAKASAGO),SMC-USA,NITTO, ROLLON AIGNEP AIRLOC FLEXLINK ,KITA, HUMPHREY
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CATEGORIZATION
Distribution, Representative, Integrator, Sub-Contractor
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AREAS OF ACTIVITY
Pneumatic & Mechanical solutions, Robotic Cables and cable carriers, Motion Control, Military & Aviation products, integrated solution for machine builders.
DSM Biomedical is a part of Royal DSM and the world’s unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare. For more than 30 years, the company has been at the forefront of biomaterial science and process innovation, and the leading resource for global medical device and pharmaceutical companies.
As a strategic partner with an approach driven not only by market dynamics but by the unique needs of every customer, DSM Biomedical brings an unparalleled breadth of product portfolios, proprietary manufacturing and processing capabilities, world-class IP, and extensive regulatory experience and expertise. Furthermore, DSM Biomedical’s products and services are recognized for their unmatched quality, consistency, and performance in multiple markets across the globe, supporting their company-wide vision of solving the world’s healthcare needs through sustainable science. To learn more, visit DSMBiomedical.com.
Established in 1955, Eastronics is the largest local hi-tech distributors in Israel. Eastronics is the leading Israeli company in sales, marketing, service and support of high-tech products, with a strong Design-In/Demand Creation activity.
The company employs a large group of highly experienced and professional Application Engineers from diverse backgrounds and disciplines, supporting demand creation / design-in activities from the early stage of the project’s definition until production. Eastronics offers its customers and principles a long-term and mutually beneficial business partnership with a leading, innovative and people-friendly organization
"From Idea to Product" founded at 1995 - a product design and planning company. The company employs experts in various fields: product design, engineering design, prototype builders and manufacturers of product portfolio for production.
We take full responsibility for the entire process so there is a close connection between every line we design and the production process.
Our work, throughout the project, involves an industrial designer, mechanical designer, materials specialist and model builder.
At every stage of the work, all staff members are involved.
Everyone controls the process according to his/ her area of knowledge and expertise. Therefore, the product comes to production stage without any unexpected surprises.
This is the way we work:
We work closely with the customer's development and / or marketing team. We integrate in the early stage of the characterization, design the product configuration.
We handle human factors and user experience;
We design the product parts to suit the serial production process defined for it.
We build a prototype for testing and with the customer's approval;
We produce product files for production.
It’s up to the customer to choose what our level of involvement in the project. We can do part of it, or do it all.
Visit us in our website
Look at our product video
Gezellig Scientific is a creative and innovative company founded on the idea of providing much needed support and customized solutions to the complex and dynamic Regulatory and Quality requirements impacting the Medical Device Industry. By establishing strong partnerships with medical device manufacturers, seamlessly integrating with their customers to understand their unique needs, Gezellig Scientific is able to create custom-tailored solutions to every situation to provide a comprehensive and “worry-free” experience for their customers. Gezellig Scientific recognizes that speed is what counts for customers to gain or maintain a competitive edge in today’s highly demanding market, while also keeping budget and expenses in sight. With a strong scientific background and expertise in Medical Device Biocompatibility, Sterilization/Sterility Assurance, Clinical Evaluation, Risk Management/Quality Processes, and Regulatory Affairs, Gezellig Scientific provides a broad array of support models to aid organizations of any size achieve their goals.
Gezellig Scientific is positioned to help manufacturers with their regulatory and compliance needs that span from global product submissions to product remediations/deficiencies, to compliance and regulations changes (i.e. MDR). Through development of proprietary methodologies for analyzing chemical data, the Gezellig ChemTox TM toxicological risk evaluation process represents a paradigm shift in how analytical chemistry data is handled and provides clients with rapid assessment of even the most complex chemistry results.
Global R&D Ltd is a dynamic and innovative research and development company that was established in 1995. We offer one-stop solutions for integrated multidisciplinary projects in the fields of Hardware(Analog and digital), Embedded Systems, Software and Mechanical engineering. Our team utilizes the latest technologies to provide innovative and productive solutions for our customers.
We are experienced in handling a complete project, from concept through the design and prototype to the final product delivery and serial production being an outsourcing R&D team that provides cost and time effective solutions for development projects.
We provide a risk-free complete answer for the electronics development and production of electronics for startups, and the most efficient way for any company to develop any card or system in the shortest time to market schedule.
Global R&D has ISO 9001:2015 certification and is an authorized supplier of IAI and MOD
Gsap is a service provider for healthcare companies, providing end to end services throughout the life cycle of medical products. Gsap aspires to enhance the development and maturation of healthcare companies, pharma, medical device, cell therapy, medical cannabis, digital health and IVD companies. We help companies by accelerating the development of safe and effective medical products for patients worldwide.
HaMaDa is a prominent RA/QA/CL consulting firm possessing 15 years of Regulatory, Compliance and Clinical Affairs experience for Medical Device companies. Its professional, multidisciplinary team of 30 industry and scientific experts have been supporting leading companies in a wide range of expertise domains such as Active and Non-Active devices and Implants, In Vitro Diagnostics, Digital Health (Medical Apps, Wearable, AI and Big Data), etc.
HaMaDa has the vital experience necessary to manage the regulatory approval process, Clinical documents and processes and provides a wide range of services, for start-ups as well as established companies.
For early-stage companies, HaMaDa is crucial in defining the best strategic and tactical plans to pave the way into the market and implement these plans to achieve marketing approvals in various geographies.
For well-established companies, HaMaDa complements in-house expertise to assist with specific quality and regulatory activities, such as compliance with MDR, IVDR, MDSAP compliance preparation of documentations such as CER, PMS, PSUR, useability plans and studies, provide training for personnel or execute internal audits of the QMS, Clinical Studies and/or ISO 13485 quality system. HaMaDa may also serve as your CRO for Clinical Studies in the most advanced technological fields.
Healthier Globe is a strategy and investment advisory firm dedicated to serving start-up and established medical device companies of all sizes.
We assist companies that want to scale internationally, helping them gain market positioning and accelerate their sales in new markets while
providing access to the whole ecosystem of providers.
Healthier Globe Teaches Entrepreneurs How To Raise Company Value and Get To Market Effectively and Efficiently Through Coaching, Mentoring and Bootcamps
While in The Process Helping Build Global and Local EcoSystems; Obtaining Manufacturers, Strategic Partners and Investors
Our mission is to assist our clients in building state-of-the-art medical device companies and lead them to success.
With more than 500 life sciences and health care lawyers across the globe, we work closely with you and each other to tackle tough issues and difficult-to enter markets – no matter where you are today or want to be tomorrow. And because we know what makes your industry tick, we have a deep understanding of the issues you face – helping you stay ahead of the curve and on top of your opportunities.
Across the full product life cycle, from initial clinical trials to off-patent strategy, from business development to defending complex litigation, we provide our clients in the pharmaceutical, medical devices, and biosciences industries with an in-depth understanding of the issues affecting their business and the legal solutions they require to compete in a competitive global marketplace. Our cross-disciplinary approach, the deep bench of talent across disciplines, and our knowledge of and relationships with European, Asian, and U.S. government agencies, enable us to help clients operate or expand globally and achieve their long-term business objectives.
Integer is a leader in advanced medical device outsourcing, bringing unparalleled expertise and comprehensive solutions in innovation and manufacturing to customers. We meet today's medical device challenges by providing customers with the right solutions, access to new technologies and a breath of capabilities. Our brands include Greatbatch Medical and Lake Region Medical.
For over 30 years, ITEC is at the forefront of Israel’s fast developing hi-tech industry, representing international leading manufacturers of Materials properties testing systems , software and hardware solutions.
ITEC specialized sales & support engineers assist customers from the early stage of design, development , quality control and verification throughout their product life cycle, aiming to keep a high level of satisfaction and preserve long-term relationships.
By operating in all the different market segments: Industry / High tech / Semiconductors / Automotive / Aerospace / Packaging & Medical devices, we strive to provide innovative products and technologies required today and anticipated for the future. This to ensure that customers maintain a competitive advantage in their marketplace.
We deliver quality and cost-effective solutions combined with Pre & Post sales services that provide added value based on extensive knowledge of technologies and methodologies, to meet specific requirements and realize tangible results.
Clean Room Solutions Ltd." is a trusted provider of clean room solutions established in 1996. The company offers a wide range of services including disinfectant application, cleaning materials, and the effective management of production support workers. With a deep understanding of the critical processes in clean room production Clean Room Solutions Ltd, Ltd." offers expert solutions for efficient and cost-effective operations. Trust Clean Room Solutions Ltd." for all your clean room needs.
LAHAV C.R.O (contract research organization) is Israel’s largest contract research organization for pre-clinical studies specialized in large animal studies. We flexibly full support and customized programs from proof-of-concept non-GLP to large-scale GLP studies
LDP Consulting offers support for your project and/or specific services to meet your needs, getting your FDA Clearance/ CE approval, planning and executing clinical trials and establishing your quality management system.
The Regulatory team will help you establish your US and EU regulatory strategy; prepare submission to regulatory authorities, such as Q-submission, 510(k) and AMAR submission; technical documentation, including biological evaluations , clinical evaluations , PMS and PMCF, PSUR and more.
The Clinical team will help you to prepare clinical study documents in compliance with applicable guidelines. In addition, we can assist you in the management of your study: site identification and selection; training of relevant team; study compliance; safety management, monitoring activities and we can lead GCP and ISO 14155 audits.
The QA/RA team will support and guide you in different activities related to your Quality Management System (QMS), according to the project’s scope and needs. In particular, we can assist you in the establishment of e-QMS, maintenance, support the R&D Team in design control activities and related processes, including risk and usability process , change control; lead and support the Production Team in development and maintenance of the Device Mater Record (DMR); plan and lead internal audit, supplier audits; external regulatory audits and promote audit readiness within the company.
Israel's leading provider of software development, regulation and cybersecurity services for the healthcare industry.
A one-stop shop for medical software companies, startups, and healthcare organizations, Matrix Medika has the experience and expertise that come from helping bring over 100 successful projects to market. We help companies design and develop innovative solutions, services, and desktop, mobile, and cloud-based apps; ensure rock-solid cybersecurity and privacy in compliance with HIPAA/GDPR standards; and manage FDA/CE submissions.
Our specialization in the medical arena means you can trust us to handle V&V per IEC62304 and ISO13485 standards, risk management per ISO14971 and TIR57, preparing the software chapters for FDA 510K submission and CE certification, and registration under MDD and MDR.
We’ve helped countless products through every stage of the development and FDA/CE approval process, and we’re fully committed to ensuring client satisfaction, quick time to market and cost-effective solutions. At Medika, we’re there for you at every step of the way.
MedDemand is a B2B marketplace that precisely matches MedTech customers with relevant suppliers, vendors and sub-contractors.
Finding the right vendor can be time consuming and exhaustive; from searching the internet, asking colleagues, or spending hours researching potential vendors. The solution is MedDemand – an online B2B marketplace dedicated to the MedTech industry, where all you need to do is share your demands with our network, and the offers come to you.
In order to reach your relevant vendors - Send a ‘Demand’ via www.MedDemand.co, detailing the kind of suppliers, vendors or sub-contractors that you’re seeking.
Your ‘Demand’ is then sent to our sister platform - DealSwap (www.dealswap.co), a network of trusted and established vendors, all committed to offering you the best service.
Each relevant vendor will get in touch with you, outlining exactly what they’re offering.
With all these offers in one place, you can directly communicate with the providers that best fit your needs.
Microtech Ltd. is structured in four main departments:
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Metallography: Metallographic sample preparation and Microstructure analysis.
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Material properties: material testing including mechanical properties, chemical composition analysis, Coating thickness measurement using X-ray fluorescence (XRF) and Optical Emission (OES) technologies.
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Optical Microscopy: special expertise in industrial and material science applications
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Dimensional Metrology: Length, Form and Surface measurement, for both contact and non-contact 3D scanning.
Trusted for nearly 60 years, Phillips-Medisize, a Molex company, is a global leader in front-end design, development and manufacturing solutions for highly regulated industries — pharma, diagnostics, med tech, consumer, automotive and defense.
Operating as a single integrated collaborator, we help our customers reduce risk and achieve product realization quickly and efficiently. Our innovation, quality and reliability enhance the lives of millions of people around the world.
Founded in 1993, Prodrive Technologies designs and manufactures high-tech electronics, software, and mechatronic products and systems that are extremely efficient and often unique.
We operate six dedicated R&D programs, three highly automated manufacturing sites, and sales offices in the Netherlands, the U.S., China, Israel, Germany, and Japan.
Everything centers on the customer, our passion for technology, and constantly improving our business processes.
We do everything in-house and use the very latest process techniques, many of which we have developed ourselves. As a result of this innovative approach, we are among the fastest-growing technology companies in Europe.
Our mission is to contribute to innovations that tackle major challenges in society, such as improving the quality of medical imaging to recognize diseases earlier and more accurately. Besides, our technologies also contribute to reducing the global dependency on fossil fuels and to minimizing human exposure to air pollution.
In other words, we create meaningful technologies that make the world work.
ProMedoss was created to support medical device startups and entrepreneurs to bring medical devices to market in a fast, efficient, and cost effective way.
We provide services which include full support in regulatory compliance, clinical trials, quality management systems, risk management, as well as due diligence and reimbursements.
Our team fully understands the complexities involved in advancing a product from concept to market.
Our regulatory experts have successfully assisted a variety of medical device companies, ranging from startups to large scale manufacturing companies.
Company website: www.promedoss.com
QMED Lingua is the Life Sciences Division of Q-Lingua Translation & Localization Services Ltd., providing end-to-end translation, content validation, technical writing, voice-over and all other language services - in ALL languages specifically to the medical device, pharma and digital health community. QMED-Lingua is ISO 17100 (EU) certified, supporting companies from startups - to pre-IPO and globally active enterprises in their medical, clinical, marketing, financial, legal, user-application and regulatory requirements - committed to their success in every market, culture and language.
The Ready Group has been Israel's leading R&D service firm since 2007. The group’s wide range of technical expertise enables the next generation of technology and products of leading multinational and Israeli companies as well as innovative startups in various stages. With over 200 professionals in various technical domains, we provide chip and software development services. Our chip development services range from architecture, design and verification to full manufacturing. Our software experts are skilled in real-time and embedded systems, Object-Oriented programming as well as Mobile and Web applications. We have also been working on many Validation, QA and automation projects.
Relcom was established and operates since 1979.
In the beginning of 2006 Mr. David Arad established Relcom Components Ltd. Which is oriented to the Military, Space, Avionic & Medical Industries.
Relcom Components Ltd. Is a representative and Distribution organization of Electronic, Electro-Mechanic and Servo & Motion control Components. Our manufacturers are from USA, Canada, and Europe.
Supported by our Hi-Technology innovative principals we provide wide range of products to our customers in the Israeli market.
Introducing Remidio - a trusted name in the world of technology and engineered medical device manufacturing. As a global leader in this field, Remidio caters to clients across the world with its top-quality medical devices. With a focus on design, development, regulatory, engineering, and manufacturing, we offer a wide range of custom solutions tailored to meet the unique needs of our clients in the healthcare industry.
At Remidio, we take pride in being the ISO 13485 certified, US FDA audited, MDR – Audited & cleared (for Product) medical device manufacturing company in India. We operate from a state-of-the-art 15,000 square foot medical device manufacturing facility in India, equipped with cutting-edge technology to ensure precision and accuracy in our products.
RS NESS Provides An Umbrella Of Services To The Life Science Industry In Different Lifecycle Stages Incorporating End-To-End Project Activities While Adhering To The Regulatory Requirements. Knowledge, Professionalism, And Dedication Lead Our Highly Qualified Team To Your Success.
RS NESS Operates In The Pharmaceutical, Biotechnological, Medical Device, Cannabis & Foodtech Industries.
Our Services Include End-To-End Solution
Solution to products ltd. (S2P ltd.) specializes in the development and production of high performance plastics, aluminum, metal and silicone parts for:
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Electronics, telecommunication and electro optics
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Medical equipment and accessories
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General Consumer products
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Electrical appliances
Scopustech a manufacturing company specializing in the production of transparent products for over fifty years. The company manufactures with a variety of different polymers. Among them, polycarbonate (PC), acrylic (PMMA), antistatic PVC, acetyl (POM / DELRIN), and more. The company’s products are used as parts and subsystems in complex and sophisticated systems in the defense industries, medical equipment, printing, optics, light transmission and more.
Simploud enables medical device and digital health companies to manage their quality, design, documents, and suppliers in compliance with regulatory requirements.
Simploud offers ready-to-use best practices that provide a great starting point. The system was designed with flexibility in mind, so it could be tailored to specific needs easily, at no additional cost, and in a validated manner.
Singer Instruments & Control specializes in design, development and manufacturing of medical device for over 40 years.
We provide our clients full turn-key solutions: From proof-of-concept prototype design to final products serial production.
SKM Aeronautics is a leading boutique manufacturer of customized and precision rubber sealing solutions.
Certified to quality standards ISO13485 medical devices, AS9100 aerospace and aviation, and ISO9001 industrial standard, and with over 60 years of practical experience in the core of the rubber industry, SKM provides reliable and innovative sealing solutions to meet the most demanding of end-user applications, in industries such as aerospace and aviation, military and defense, medical devices, communication and electro-optics, energy oil and gas, semiconductors and automotive.
We can safely say “we’ve rubbered them all” !
The Standards Institution of Israel leads the Israeli economy in the writing of standards that ensure the safety and soundness of products, laboratory testing, services, and processes that touch on all aspects of our lives.
The Standards Institution of Israel is the country's largest technology entity. Its operations assist all sectors of the economy. The Standards Institution of Israel operates pursuant to the Standards Law, with a focus on the following fields: Standardization, Authorizations and Certifications and Testing labs.
The Standards Institution of Israel is part of the international quality community and an active member in international standards and certification organizations, including the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO).
The Standards Institution of Israel has recognition agreements that facilitate foreign trade.
Sternum introduces a first-of-its-kind IoT security platform/infrastructure that protects billions of devices by injecting security and observability into IoT device mindset. It prevents exploits and zero-day attacks while providing unprecedented metrics and visibility into the performance, health, and integrity of the device and device fleet. It allows manufacturers, enterprises, and institutions to enjoy optimized device operations and focus on their core business.
Systematics promotes organizational effectiveness and efficiency by marketing innovative computing technologies and implementing them in advanced work processes.
Technologies marketed, distributed, and supported by Systematics include:
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Geographic Information Systems (GIS)
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Computer-aided design and product lifecycle management systems (3D CAD/PLM)
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Tools for technical and scientific computing (model-based design)
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Three-dimensional (3D) printing technologies
Computing solutions are implemented for customers by company experts. Advanced methodologies ensure brief implementation time and measurable improvements in organizational efficiency and competitiveness.
An entire infrastructure, including service, marketing, and training, supports thousands of customers. A wide range of courses and training sessions, advice and consulting services are tailored to the customer’s needs. A computerized service center is staffed by teams of experts. Seminars, newsletter updates, and professional network support sites are part of the all-encompassing support network.
Systematics’ solutions serve more than 3,500 organizations in the Israeli market. Customers include institutions from the worlds of industry, government, public sector, military and defense, finance, commerce, and academic institutions.
Systematics has been providing top-quality solutions and services since 1979. Its offices are located in Tel Aviv.
The company is accredited for ISO 9001: 2000 and ISO 9000-3: 1997 standards.
Taryag Labs
Taryag Labs provides first-class testing services and validations in analytical, microbiological and transportation fields for medical devices and pharmaceutical products.
Taryag Sterilization
Taryag Sterilization offers end- to-end integrated services, including manufacturing, assembly, packaging and sterilization validation that allows our customers rapid and effective release of the product to market.
Würth Elektronik eiSos is one of Europe's leading manufacturers of electronic & electromechanical components. Together with Wurth Electronics Midcom, Würth Elektronik iBE, Erwin Büchele and Würth Elektronik Stelvio Kontek, Würth Elektronik eiSos ensures a high availability on all markets. More than 700 sales representatives worldwide make up a direct sales network that is unique in this industry: Local Design in support, all catalogue products in stock and samples free of charge is the promise to our customers. Würth Elektronik operates production plants in Europe, America and Asia. More than you expect!
Yail Noa group is a representative of leading suppliers offering vast variety of products to the Pharmaceutical, Medical devices and Electronics industries.
Yail Pharma is a business unit of Yail Noa Group, specializes in protective packaging solutions for the Medical Device and Pharmaceutical markets.
The company supports its customers with personal high level service and strives to meet the highest standards in order to provide the most suitable solutions.
Among our customers are companies from the following markets: Cardiovascular / Neurovascular /Orthopedics/ Dental/Endo/Aesthetic/Surgical / ophthalmic/ Oncology etc.
Yail Pharma works closely with both start-up & mature companies and leads them throughout the process of developing and manufacturing the proper packaging solution.
Main Product lines :Rigid Thermoformed Blisters, Sealing Machines, Sterile Pouches/ Lids /Rolls.
Vendors represented In Israel: Nelipak, Oliver Healthcare packaging, Clariant, HAWO, Carolex, AllFlex
Zriha medical specializes in manufacturing solutions for the medical industry, providing full support under one roof.
We offer services starting with product design and prototyping, through mold design and production, injection moulding, assembly and other complementary services in a Class 8 cleanroom.
We work in accordance with the medical quality standard - ISO 13485.