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For over 40 years, NAMSA has been the world’s leading company specializing in the safety evaluation of medical devices.

Serving the regulated health care industry, NAMSA offer testing services to device manufacturers, raw material suppliers, pharmaceutical companies, sterilizers and related businesses.

NAMSA’s expertise and experience enables to provide consultation at various phases during the product development life cycle, develop specific testing programs for medical products and provide continued support through regulatory submission, defense and approval.

In March 2008, NAMSA & MedicSense signed a partnership agreement. According to this agreement, MedicSense is the official exclusive sales representative of NAMSA in Israel. Medicsense experience will assist NAMSA’s clients in Israel in complying with international standards as well as worldwide regulatory organizations.

For more information on NAMSA’s testing services and products, please visit www.namsa.com.

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For over a century The British Standards Institution (BSI) has been helping businesses to raise their performance, compliance levels and enhance their competitiveness worldwide. BSI works with business experts, government bodies, trade associations and consumer groups to develop and implement standards and regulations and structure the knowledge all organizations need to succeed. Among the many services that BSI offers

are development of standards, quality system and product certification, providing specialized training courses as well as offer compliance tools and software. With over 650,000 customers in 150 countries and 58 offices worldwide, BSI provides global market access through training and certification to its clients worldwide.

BSI now brings its services for the medical device industry to Israel. In 2012, BSI has started to offer its Notified Body certification services, supporting Israeli manufacturers with access of their medical device to the EU and other international markets. By launching in 2013 its training courses in the Israeli market, Israeli medical device professionals can now also benefit from the knowledge and experience of one of the largest and best recognized Medical Device and IVD Notified Body in the world

Starting in April 2013, MedicSense will offer BSI certified courses such as ISO 13485 internal auditing, ISO 13485 lead auditor course, EU MDD, EU IVD, building effective Technical and Design Dossiers, Risk Management and more. BSI has contracted with MedicSense to manage and deliver the BSI Academy training portfolio in Israel. MedicSense has a long and successful history in the medical device sector and will bring its local expertise to support BSI with its training activities in Israel.

For additional information about BSI please visit http://medicaldevices.bsigroup.com

CEpartner4U is an independent Authorized Representative firm, staffed with a team of extensively experienced regulatory affairs professionals and former Lead Assessors of a Notified Body.

CEpartner4U offers MedicSense clients special rates for Authorized Representative services of the highest quality. For more information about the role of the Authorized Representative go to Services.

For more information about CEpartner4U please visit www.cepartner4u.com

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Med-Dev Design is a professional boutique company, that specializes in medical software development and V&V solutions. The Med-Dev Design team of exceptional software engineers bring more than a decade of broad range experience in developing and verification of medical devices.

Company services cover all aspects of medical device development, including: product and project management, software design, software development, software architecture, software verification and validation as well as documentation for the regulatory bodies.

Med-Dev Design offers a wide range of solutions tailored to customers’ requirements for companies in all stages. Med-Dev Design customers enjoy engineering support of the highest possible standards, in design and development of medical applications, and in continuously improving and perfecting medical device products.

Med-Dev Design has developed and regulated medical software for leading companies and start-ups in the medical field.

Med-Dev Design and MedicSense successfully cooperates for the last years.

For additional information about Med-Dev Design please visit
www.meddev-design.com

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“Matrix Requirements Medical” is the simple and efficient Device Application Lifecycle Management (ALM) software supporting standards as ISO 13485, IEC 62304, IEC 62366 and ISO 14971. The software fully complies with FDA 21 CFR part 11 for Electronic Records and Electronic Signatures.

Matrix Requirements and MedicSense joined forces and designed “Matrix Requirements Medical”, a simple and pragmatic for traceability of requirements, risk management and generation of DHF, DMR and DHR documents.
MedicSense is the exclusive representative of Matrix Requirements in Israel.

For additional information about Matrix Requirements please visit https://matrixreq.com/

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特拉维夫 – Global – Techcode

Techcode is an organization focusing on incubator operations management and dynamic growth of science and technology entrepreneurs. And it is dedicated to becoming the No.1 brand for of global innovation and entrepreneurship ecosystems eco-system.

Techcode-Tel Aviv’s mission is to help Israeli startups connect, penetrate and event relocate to China.

Techode and MedicSense successfully cooperates since 2016.

For additional information about Techode please visit www.techode.com.

MedicSense has joined forces with Synergus, a Swedish MedTech Consulting company, to provide our clients with a wider scope of services.

Synergus and MedicSense have made an agreement where MedicSense will represent Synergus and offer the following services:

  • Regulatory compliance in the Far East (Japan, China etc.)
  • Reimbursement in Europe
  • Electrical safety and EMC consulting (according IEC60601 standard) series) including Q&A Hotline operated by an expert who contributes in the IEC Committee
  • Business Development in Scandinavia.

More information about Synergus can be found at: www.synergus.se

MedicSense is working with Latham & Watkins, LLP a highly acclaimed international law firm on reimbursement matters. Latham & Watkins assists Israel medical devices companies with the reimbursement process in the USA and Europe.
Reimbursement is a crucial factor one must consider and address already in the early stages of a device company’s development. Exclusion from healthcare insurance programs might undesirably result in exclusion from an entire market.
Building a comprehensive reimbursement strategy and evaluating its prospects are also important for device companies and investors who are seeking to minimize their risks.

For additional information about Latham & Watkins please visit www.lw.com

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MedicSense introduced a new service to the local industry, following an accord signed with “Latini & Associados”. The new service includes registration services in Brazil and working within ANVISA regulations, the Brazilian Authority for the registration of medical devices and other medical products.

“Latini & Associados” is one of the largest RA Companies in Brazil providing Regulatory Affairs services in Brazil for:

  • Medical Devices including IVD, Equipment, Consumables and Disposables
  • Cosmetics and Perfumes, including personal hygiene products
  • Pharmaceutical products
  • Food, including Food Supplements
  • Sanitizers

The agreement between MedicSense and “Latini & associados” enables us to assist medical device manufacturers and other companies in the medical field in introducing their products in Brazil. It is crucial to have a professional and experienced focal point in Brazil to assure a fast and effective process.

For additional information about Latini & Associados please visit www.latini.com.br