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



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.

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

Yana Katsman Magen

Project Manager

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

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.

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.

Meital Stein

Project Assisstant

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

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