Li-Med was founded by Asaf Azulay, Certified quality and regulatory consultant with over 20 years of experience in both domestic and international medical companies.

Li-Med’s team consists of seasoned quality and regulatory professionals with many years of industry experience. Adopting an extraordinary work ethic and deploying industry best practices, Li-Med’s team has managed to consistently exceed its clients’ expectations.

Team Certifications and Experience

ISO 13485 & 21 CFR Part 820

FDA clearance and approval

CE approval

Design control and good manufacturing practices (GMP)

Software As Medical Device (SAMD)

Validation and Verification

Combination Products, including device, drug, and biologic products

Medical Cannabis products

Microbiology and biocompatibility

ETO Sterilization

The Team

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Asaf Azulay

Founder & CTO

Founder & CTO of LI-Med. has extensive experience in both the Israeli and global medical devices industry. Asaf has over 20 years of experience as a quality team leader, and QA/RA consultant. Asaf has vast experience in determining the appropriate regulatory strategy and helping clients to achieve and maintain desired regulatory approvals


Orly Shenkar

VP Projecs

Over 7 years of experience in Quality and Regulation of medical devices including Active, Active Implantable, Class III and Software Devices.

Manages, builds and implements full Quality management systems, establishes and submits Technical files/Design dossiers and supports FDA submissions.

Michal Wilensky Yahav

Director Projects

Over 13 years of experience in Quality and Regulation of pharmaceuticals and medical devices.  Supports clients in leading the quality and regulation strategy, directing all departments towards proper Quality System implementation that will ensure regulatory approvals. Involved in the design and development stages through post-production activities of non active devices and combination products.

Sivan Gal On

Project Manager & Marketing

Marketing and customer relations Manager
20 years of experience in sales and marketing, responsible for publications in social networks, professionals meetings and workshops. Projects Manager for Eurofins BioPharma testing lab projects.

Dafna Goldberg

Office Manager

Responsible for bookkeeping, suppliers and purchasing

Elisheva Radle-Dessiatnik

Project Assisstant

Has a strong background in the medical and dental fields. Currently gaining experience in Quality and Regulation of medical devices.

Sally Bercovich

Biocompatibility & Sterilization Expert

More than 12 years experience in the quality assurance field. Possesses an extensive practice in Biocompatibility, derived from dozens of ongoing FDA & CE complaint projects. In addition, has expertise as an ETO Sterilization Validation & Re-Validation projects and test strategic manager, derived from more than 15 FDA & CE complaint projects.

Inbal Levy

Project Manager

Over 9 years of experience in Quality and Regulation of pharmaceuticals and medical devices. Managed, built and implemented full Quality management systems as well as Technical files/Design dossiers of various devices, including Active, Active Implantable, Class III , Software Devices and non active devices.

Yafit Kapilov

Project Assisstant

Holds over 5 years of experience in engineering from a medical device company and currently gaining experience in Quality Assurance.

Shahaf Levy

Project Assisstant

Certified Quality Engineer (CQE and ( Mechanical practical engineer. A Quality Control & Quality Assurance expert with 3 years experience in the field of medical devices and dental, and in managing and maintaining Quality Management Systems as well as Design Dossiers.

Meital Stein

Project Assisstant

An experienced regulatory affairs Coordinator with experience in both veterinary pharmaceuticals and medical devices.

Amiran Refailov

Project Assisstant

Electronics engineers with a broad technical understanding. A Leading quality control expert in the field of medical devices with 9 years experience of quality standards (13485, 9001).

Yana Katsman Magen

Project Manager

Has a background in managing and maintaining Quality management systems as well as Technical files/Design dossiers.

Galit David-Kadoch

Project Assisstant

Marketing and Customer Service
Biocompatibility technical support for medical device and pharma.
Currently gaining experience in Quality and Regulation of medical devices.

Rebecca Feldman

Project Assisstant

Experience in Quality and Regulatory Affairs for medical devices with experience in US, EU, Israel and international regulation and implementing quality management systems.

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