SemIsrael Technology Week - a week full of technology!
three days dedicated for semiconductor professionals and one day dedicated for medical devices professionals. 

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Medical Devices Technology & Regulation

March 22, 2018
8:30-16:00
Camilo (Green House), 24, Dr. George Wise St., Tel Aviv

The most focused event for the medical devices sector!
Uniquely tailored for medical devices professionals.

 

We offer free registration for medical devices professionals, working for local medical devices companies.
 

Why should you attend the Medical Devices Technology & Regulation conference:


- Come and meet the Who's Who in the medical devices space
- Get the most updated current technology and know-how from leading vendors

- Get the most updated current regulation and clinical know-how from leading vendors
- Best networking event
- Enjoy the unique ambiance and quality of SemIsrael professional events

*** Please note the dual track structure of the conference: Design Track, and Regulation Track (detailed agenda of both tracks below)

Please note that registration to the conference is now closed, while registration to Gsap workshop (starting 14:30) is still open.

Conference Sponsors:

Come & Meet Our Exhibitors:

Almond® is a tool for managing the development of medical devices, that can save up to 2 years in the design and development process of medical device products; all in a secure cloud environment.
Almond® leads the development process while ensuring compliance with regulatory requirements (21 CFR Part 11, ISO 13485:2016 and 21 CFR Part 820), maintaining the development history and indexing for all documents to enable quick and easy access to all files based on authorizations.
Almond® was established after many years consulting and accompanying the development process for numerous medical device companies with Gsap®, a leading consultation company in the medical device space.
Almond® is dedicated entirely to management of the medical device development process.

Aran is a leading Israeli product design and development firm and an exclusive agent of global equipment and raw material suppliers for the plastics industry.

Aran provides customers with comprehensive medical product development services – from inception to product market launch - including user research, design input, early risk management, system engineering, concepts, detailed design (mechanical, electrical, SW, FW, industrial design), V&V and transfer to production.

The company additionally facilitates plastic injection molds, manufacturing and assembly services – from models and prototypes to small scale manufacturing and serial production in its fully integrated facility and quality management system (ISO 13485:2016, AS9100) and its class 7 cleanroom.

arazim Ltd is leading supplier of sensors and systems for the medical market for more than 20 years now.

Among our product line you can find  –

 

  • Nano-Power Ultra-miniature Biomedical Switch

  • Ultra-miniature medical camera with Optics for endoscopic applications

  • Ultra-Low-Power ASICs , Sensors and SoC design solution

  • Multi-Sensors-on-Chip solutions

  • Zero-Power mechanical motion switches

  • Low-Power Wireless solutions (BLE, WLAN ,LoRa)

  • Various sensor solutions

  • and many more…

 

We do provide technical support , development & integration services and more.

arazim Ltd is ISO-9001-2015 certified company.

With extensive knowledge of the commercialization process, regulatory requirements and scientific trends in the Industry, Eurofins Medical Device Testing offers regulatory compliance expertise and experienced GMP/GLP/ISO 17025 testing to ensure rapid turnaround times with the highest level of service and most advanced technologies for your analytical chemical, microbiological, biocompatibility, electrical, mechanical and package testing needs. 

Our scientists and engineers have been assisting companies, large and small, with developmental testing for more than 25 years; and our global network of 16 laboratories in North America, Europe and Asia Pacific provide extensive capacity and the highest level of instrument technology with a full scope of testing services.

FIM has long-standing experience and expertise in dealing with extraordinary challenges, generating optimal solutions in the development of fine mechanics and maximizing the technical capabilities of any product.

Our team is creative, skilled in finding solutions to challenges, and possesses a highly- developed ability for inventive thinking and resourcefulness.

Our company is founded on cooperation between the various teams, thus enabling the advancement of an idea through advanced research and development until its realization via the workshop and production department.

The process focuses on providing an optimal solution, customized design, timetables, pricing mechanisms etc.

The company provides a wide array of solutions for the development and construction of prototypes for preclinical trials.

The product undergoes a complete process from concept to production, including metal parts, plastics and laser welding.

FIM is currently in the process of obtaining approval for ISO standard 13485 for assembling medical equipment in a clean room and serial V&V production.

Gsap is the leading consulting firm in Israel for providing professional services to medical devices and pharmaceutical companies. The Company aspires to enhance the development and maturation of Israeli medical device companies and to empower their employees to achieve significant resolutions for patients worldwide.

In each of the projects, the staff members lead complex decisions and bring their personal experience and the benchmark customary in the industry, as well as the most advanced methodologies, to enhance the achievement of the companies’ goals.

Since 2009, Gsap has served more than 200 device companies, from start-up to large international companies.

Among its clients are start-ups such as Syqe Medical, Precise-bio, Lyra Medical, Apifix  and more, small to medium sized companies such as CME, Medimor and large companies such as Philips and Biosense Webster. In Gsap consultation portfolio you can find Class I Class II  and class III Products.

Click here for more information

Jonathan Bar-Or Industrial Design Ltd. is one of the leading product design and development companies in Israel.  

Our expertise is designing ergonomic solutions of high aesthetic quality that interact with the human body.

We provide a comprehensive product design and development process including design and engineering, early concept development, modeling, packaging, user-guide design, and complete product files for production.
We act as a development team with our customers – start-up ventures, as well as mature companies. Our focused design process leads us, together with our clients, to successful results, with a high level of certainty within strict time constraints. These accomplished results have been recognized with prestigious international awards and publications.

Contact: office@jbdesign.co.ilhaya.belkind@gmail.com

L&T Tech Services is a global Engineering & R&D company, servicing a large number of Fortune 500 companies. We have over 25+ years of Medical Product Development expertise with over 400 design engineers exclusively working for Medical domain delivering services to Medical OEMs globally.  With certifications in ISO 13485, CMMI- Level 5 ver1.3, ISO 9001, ISO 14001 and ISO 27001 we’ve been engaged with customers at every stage of the product development lifecycle and have contributed significantly to their growth by developing & infusing cutting edge technology in their products while reducing cost and development schedule due to outsourcing some of the work to our development center & labs located in Israel, US, Europe and Asia. Our office in Jerusalem includes more than 100 engineers working on various projects in Israel and abroad.  Some of the services include:

  • Product Development (Hardware, Embedded software, Mechanical )

  • Algorithm Development in Image processing, Application Software Development

  • Connectivity Solutions (DICOM & HL7)

  • Validation & Verification

  • Regulatory compliances – FDA ,CE, 60601-1, 3rd Edition Compliance, RISK as per ISO 14971, IEC 62304

  • Product Compliance – EMI/EMC, REACH, ROHS, Conflict Minerals

  • Sustaining management and VAVE projects

For additional information, please visit www.LntTechservices.com

Arazy Group Consultants Inc., an international consultancy spanning several continents, assisting medical device companies with regulatory compliance submissions as they enter new markets. Founded twenty years ago, we now operate in over 100 countries around the world. We have been serving early start-up, medium-sized, and top 100 multinational MedTech companies, and the greatest lesson we have learned through our practice is this:

The future of a medical or diagnostic device manufacturer does not depend only on their ability to innovate; it depends also on their ability to get their products to market.
Our service technology tool, customized management software, and integrated expert network optimize planning, process control, and resource management for the entire product regulatory life-cycle.

Since 2007 Li-Med has been working with both domestic and international

customers to formulate and execute successful regulatory activities and quality

assurance, exclusively serving the medical device industry.

Li-Med serves as Eurofins representative in Israel and supports Israeli companies through the  testing processes

L.S.Marketing & Registration Added Value :
20 Years of experience in the medical device field – Offices Israel & partners EU & USA / Israeli Authorized Rep. Medical Devices for Regulatory Affairs = Same as EU Rep. in EU
EU Rep. Services / US Agent Services with our partners worldwide.

Our team comprises professionals from the medical device field - the team is proficient, focused, and includes first-class medical regulatory experts in: medical devices registrations, import of medical equipment, ISO 9001 audit preparation, dossier preparation – Israeli AMAR Registration, CE, ISO13485 and 9001,FDA , Canada ,China - all classes, business development in the medical device field, etc. 1 Stop Shop for all Medical Devices Services.

Medistat has been working with biotechnology and pharmaceutical companies for over 20 years, providing a wide variety of professional statistical and data management services for medical research

(pharmaceutical and medical devices).


Medistat is involved in development process from pre-clinical phase through phase I, phase II, phase III and phase IV (post-marketing surveillance-PMS).

Our staff has the expertise and dedication to provide you with professional services for your trail. 

NEAT Applied Technologies was founded with the commitment to provide quality solutions for Med-Tech Companies, by managing, designing and developing multidisciplinary systems, include HW, SW, FW, Mechanics. NEAT is a leading service organization dedicated to assist start-ups & well established companies to develop their own products. NEAT offers All-in-one solutions by taking your idea from its starting point and successfully carry it all the way through to final product(!), according to international standards compliance (ISO13485). NEAT’s team strength lies in the flexibility and dynamic conduct applied with experienced team, which includes specialists engineers from range of fields:  Hardware, Software, Firmware & Mechanics, who seat together and provide comprehensive solution and direct-available communication to NEAT's costumers. Over the past 20 years NEAT accumulated considerable experience in Medical Devices and IoMT Systems among others. The enormous knowledge and familiarity with wide fields and technologies allows NEAT to act with high level of creativity in order to provide the perfect solutions.

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 and reimbursements. In addition to our USA and Canadian location, ProMedoss is proud to announce the opening of our local subsidiary, ProMedoss Israel.

Join us at the exhibition for a chance to meet with Shosh Friedman, CEO of ProMedoss and Yale Corcos, Director of ProMedoss Israel.

Qosina is a worldwide supplier of thousands of stock OEM components including bioprocessing accessories, compression fittings, ENFit™ connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohy borst adapters, swabs, spikes, syringes and tubing to the medical and pharmaceutical industries. Qosina offers free samples, low minimums and just-in-time delivery.  Purchasing from Qosina saves you time and money by eliminating tool costs and providing immediate delivery of in-stock solutions from our ISO 9001, ISO 13485 and ISO 14001 registered facility.

Rachip LTD - is the local answer to the growing demand for highly-experienced, cost effective professionals for the semiconductor industry. Rachip specializes in ASIC/FPGA design and verification services, backend services and software services for the semi-conductor industry. Using advanced methodologies, a variety of development languages, and in- depth knowledge in common standard protocols, Rachip maintains the highest level and quality of products and services.The Rachip team is involved in the industry’s most advanced projects, ensuring they are continually updated on the latest technologies,methods and tools available.

Rimoni Plast, Israel's leading plastic injection molder offers a true one-stop-shop from design to mass production. In house product design & development and tool manufacturing capabilities, together with two large manufacturing plants with over 100 injection machines and 350 workers, distinguishes Rimoni from the competition.

Rimoni supports large-scale manufacturing under a variety of certifications such as ISO 13485, TS 16949, ISO 22000 and also operates a large modern ISO 8 Clean room with 10 injection machines.

Rimoni's proficiency derives from over 60 years of experience and know-how and is the backbone of each project guaranteeing high-quality, cost-effective and responsive turn-key solutions.

Softimize, an emerging leader for IoMT ('M' stands for Medical) clouds, is an optimal solution for medical-device manufacturers who decide to provide tele-health and other cloud-based values to their patients, physicians and caregivers. TBB, the Softimize IoT cloud platform, capable of integrating with any medical device, is HIPAA/GDPR-eligible, Ownable, and features unparalleled cost-performance scalability, hence is optimal for manufacturers.

TechnoSTAT is an Israeli CRO, Data Management and Biostatistics Company that has been operating for the past 20 years. We are a ”One Stop Shop” for conducting clinical trials, including data management, biostatistical consulting, statistical analysis and assistance in communications with the regulatory agencies (FDA, EMEA). We have vast experience and knowledge in all phases of clinical trials in both pharma and medical devices, from initial pre-clinical stages to clinical phases 1 through 4. We adhere closely to the industry’s guidelines and regulations implementing high quality standards. We attentively guide our clients through the various stages of the study from design to submission, working hand-in-hand to achieve their goals.

From an idea, through concept design, prototyping and manufacturing, utilizing our vast experience in the automotive, aerospace and cleantech industries, our team will lead you through the entire process to get an optimal design and a winning product. Our services includes in depth mechanical design, in house prototyping capabilities, mechanical simulations (FEA and CFD), and support throughout the process until project completion and beyond. 

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Exhibition Map & Tables Allocation

Agenda: Design Track

Moderator: Amir Shiner, VP Medical Device Development  , ARAN R&D

Agenda: Regulation Track

Moderator: Dr. Sigalit Ariely-Portnoy, CEO, Gsap

Gsap Workshop: Regulatory Challenges & News, the practical approach

 

timing: 14:30 - 16:00

To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the regulator constantly revises the requirements. In 2018 we are in the eye of the storm: from ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes are rampant and significant for medical device professionals. In the workshop we will review practical issues for implementing these requirements in the fields of usability studies, a Critical-To- Quality program and risk management requirements. Hopefully, you will get ideas that will let you safely land on shore.

Detailed Agenda:
 

1. QA/RA Challenges and Changes in 2018 (Dr. Sigalit Ariely-Portnoy, CEO) - 15 min
 

  • Last call to ISO 13485:2016 certification

  • First call to MDR implementation

  • ISO 14971 revisions

  • "Shift from compliance to quality focus" – What does it mean?

  • The moving target: MD SAP dead-line


2. Usability Focused on Human Factors (Tamar Fuerst, Practical Engineer, ICQE, Medical Device Regulatory Project Manager) - 15 min

3. Establishment of Critical-To-Quality Program (Marina Lebel, B.Sc, CQE, Medical Device Section Manager) - 15 min

4. New Tool For a Practical Approach to The Risk Management Requirements (Ossie Milanov, BA, Medical Device Quality & Regulatory Project Manager) - 15 min

 

5. Summary (Dr. Sigalit Ariely-Portnoy, CEO)