Assisting Medical Technology Companies Since 2004

ABOUT
US

Yakar Engineering is a leading consulting firm, providing strategic and technical guidance to medical device and IVD companies around the globe, designing and developing innovative solutions in a wide range of medical disciplines.

Established in 2004, Yakar Engineering is driven by a hands-on approach and professional integrity, delivering premium quality, regulatory and clinical affairs services to our clients.

The firm is comprised of Subject Matter Experts, eminent engineers and healthcare professionals holding advanced degrees from prestigious academic institutions in Israel and North America, with numerous years of experience in the fields of quality, regulatory and clinical affairs in the medical device and the IVD sectors.

Yakar Engineering provides highly individualized and comprehensive integrated solutions, diligently establishing and executing critical product design milestones, meeting all relevant global requirements, standards & directives, in an efficient and cost-effective manner.

At Yakar Engineering, we possess a wide range of contacts with senior opinion leader clinicians across a wide range of medical areas, as well as personal contacts within global regulatory agencies, making us ideally positioned to provide practical and definitive expert input, fully meeting the highest standards of quality.

Our comprehensive services and extensive experience ensure successful navigation of med-tech and bio-tech projects throughout the entire life-cycle process.

Disciplines

Medical Device

Yakar Engineering consulting expertise is built upon an in-depth knowledge of the medical device design and production life cycle.

A multi-disciplinary team of highly experienced Engineers, eminent experts in Medical Device, gained over 30 years of extensive experience in Engineering, Regulatory Affairs, Quality Assurance, Design & Development and V&V, at leading Medical Device companies in Israel, US and UK, in a wide range of medical disciplines.

Our team of experts has developed a reputation for combining high-level strategic expertise with flawless execution, exacting standards of excellence, availability and exceptional services, providing highly individualized and comprehensive medical device professional services, in D&D Project Management, painstakingly establishing and executing critical product design milestones (e.g. Definition, Research, Feasibility Study & PoC, V&V, Prototyping, etc.), fully meeting most stringent requirements, standards, directives and acts, in the most efficient and cost-effective manner, throughout the medical device life-cycle process.

IVD

IVD

Yakar Engineering has gained nearly 20 years of value creating and cutting-edge IVD knowledge transfer, in a wide range of development and regulatory conformity across the globe, meeting regulatory requirements, in an efficient and cost-effective manner.

Our experts combine business acumen and medical expertise to provide IVD companies with  unparalleled support to plan and manage product development programs and regulatory requirements, based on extensive IVD compliance knowledge, strengthening the organization regulatory competence at every point of the product lifecycle.

The IVD market has drastically increased in recent years due to technological advancements such as companion diagnostics and artificial intelligence. In addition, significant changes to the legislation governing IVDs in the EU have been brought about by the upcoming replacement of the In Vitro Diagnostics Device Directive (IVDD, 98/79/EC) with the IVD Device Regulation (IVDR, (EU) 2017/746), leading to expanded regulatory compliance across the board.

Our IVD exepertise and knowledge transfer includes technical documentation update and remediation, including risk management and performance evaluation planning and reporting.

In terms of regulatory experience, we assist and facilitate dual 510(k)/CLIA waiver submissions, while keeping current with international IVD regulatory requirements.

Regulatory Affairs

Yakar Engineering has gained extensive experience in the regulatory arena, interfacing with numerous global authorities to secure certification for our clients.

Our regulatory services include:

  • FDA Submissions and pre-market requests (e.g., 510(k), De Novo, PMA, 513(g), dual 510(k)/CLIA waiver requests, LDT, IDE, BLA, IND and NDA)
  • Coordination of EU Notified Body audits
  • Global Product Registration
  • Global regulatory preparation & submission
  • Israel Registration Holder services
  • IVD Technical File Assessment & Remediation
  • IVDD, 98/79/EC – IVDR, (EU) 2017/746 Transition
  • IVDR Readiness Audits and Mock Audits
  • Post-Market Performance Follow-Up Plan (PMPF)
  • Regulatory Strategy & Planning
  • Support for Pricing and Reimbursement

Quality Management

Yakar Engineering is uniquely positioned to assist medical device companies in full compliance with ISO 13485 and US FDA CFR820 Quality System Regulation.

Our quality services include:

  • Establishment of QMS/QSR Processes and Procedures
  • Facilitation of Medical Device Single Audit Program (MDSAP) Compliance
  • Risk Analysis & Management
  • Global Supplier Assessment & Management
  • Standards, Directives & Acts Compliance (e.g. ISO 10993, ISO 11135, ISO 13485, etc.)
  • EU Environmental Directives (i.e.: RoHS, REACH, WEEE, etc.)
  • Validation & Usability Studies
  • Design Change Management / Configuration Control Management
  • Transfer from Design to Production (e.g. PRR, FAI, etc.)
  • HIPAA & GDPR Compliance Services

Clinical Affairs

Yakar Engineering has gained extensive experience in developing and implementing clinical trial solutions, in full compliance with all relevant global regulatory standards.

Our clinical services include:

  • Pre-Clinical and Clinical Trial Planning
  • Clinical Study Protocol Development
  • Identifying and Evaluating Study Locations
  • Clinical Investigation Management in compliance with EN ISO 14155
  • Compilation and Submission of IRB Application
  • Site Management and Outsourced Site Monitoring
  • Clinical Research Organization (CRO) Assessment & Selection
  • CRO Oversight
  • Data Management & Bio-statistics
  • Development of Clinical Evaluation Reports (CER)
  • Post Market Clinical Follow-Up (PMCF) Coordination

Markets

MDSAP

Extensive experience in facilitating MDSAP compliance for Med-Tech companies in a wide range of medical disciplines, characterized with highly individualized services, in an efficient and cost-effective manner, leveraging years of experience in each MDSAP regulatory market (i.e. US, Canada, Brazil, Australia and Japan)

EU MDR

Securing dozens of MDD/MDR regulatory certificates  for Med-Tech companies across EMEA, based on robust platform of professional contacts with leading EU Notified Bodies (e.g. MDC Medical, BSI, MedCert, Intertek, etc.) and proven extensive experience in multiple medical disciplines across the European Union.

EU MDR

Israel

Providing comprehensive regulatory services, including local representation as an Israel Registration Holder (IRH) with the Israeli Ministry of Health, as well as facilitating distribution in the region for overseas medical device manufacturers.

israel

China

High level medical device and pharma compliance & registration services in China, from market strategy through dossier submission, reinforced by highly experienced China-based strategic partner.

China

Russian Federation & CIS

Assisting foreign manufacturers to get through the Russian complex mandatory requirements for time-critical approvals, leveraging  access to key institutions regulating the Russian market, notably, the Ministry of Healthcare of the Russian Federation (MINZDRAV), Federal Service for Surveillance in Healthcare (Roszdravnadzor) for issues related to medical device, drug safety, pharmacovigilance and distribution.

Partners

Yakar Engineering maintains numerous strategic partnerships around the globe with leading service providers, enhancing our ability to provide comprehensive professional services to our clients.

Yakar Engineering  is proud to maintain a strategic partnership with Methodsense, a leading FDA consulting firm, in terms of facilitating the regulatory compliance process through its direct communication channels with the FDA. With many years of experience, MethodSense provides medical technology companies with consulting services that span the entire product lifecycle and supported by LuminLogic, a robust SaaS application, developed by MethodSense specifically as a document and project management tool for regulated environments.

Yakar Engineering maintains a strategic partnership with Obelis Group, Europe’s largest consultancy center for CE Marking & European Representative Services, providing first class Legal Representative services in the EU, UK & Swiss Markets. Founded in 1998, the Obelis Group of companies (including Obelis European Authorized Representatives Center and Obelis European Responsible Person Center) operate as one of the largest regulatory and compliance centers in Europe.

Yakar Engineering maintains a strategic partnership with Cisema, one of the world’s leading Chinese regulatory consultants, in terms of facilitating the compliance process through its direct communication channels with the NMPA. This collaboration enhances Yakar Engineering’s ability to provide high level Chinese NMPA compliance services to its clients in a seamless and efficient manner. Cisema is a global leader in regulatory and compliance services for China, with 10 locations and over 100 highly qualified staff members.

ArrowFast is a global leader in Medical Device Engineering services, with 220 in-house experts, providing companies with a wide range of engineering solutions, from device planning and development through the entire medical device development cycle.

Yakar Engineering maintains a strategic partnership with MedReg Consulting, one of the world’s leading Russian Federation consultants, in terms of assisting manufacturers with the complex mandatory requirements in Russia for time-critical approvals. They leverage access to key institutions regulating the Russian market, notably, the Ministry of Healthcare of the Russian Federation (MINZDRAV) and the Federal Service for Surveillance in Healthcare (Roszdravnadzor) for issues related to medical devices.

Contact

US Office

728 Avenue U, Suite 3, Brooklyn, NY 11223                

Phone: +1-646-259-3883

Email: contact@yakar-eng.co

Israel Office

2 Ha-Shlosha St., Tel Aviv, 6706054 Israel                

Phone: +972-58-7612378

Email: contact@yakar-eng.co

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