Reglera’s subsidiary company in Israel, Reglera (Israel) Ltd., meets the increasing demand for regulatory guidance and quality assurance expertise in the growing Israeli medical device industry. Reglera (Israel) Ltd. provides Reglera’s current and future Israeli clients with a local network of support for their regulatory and quality system needs. Because Reglera’s Israel location is an extension of the US operation based in Lakewood, CO, Reglera’s experts in Israel have an extensive knowledge of the FDA’s requirements and understanding of North American and European medical device markets. With Reglera (Israel) Ltd., Reglera’s Israeli clients can enjoy Reglera’s expertise in US operations while also experiencing faster response times and better communication on the ground, effectively bridging the gap between Israel and the US medical device market. Reglera is recognized as one of the largest and fastest growing regulatory consulting and process outsourcing companies in the world, and has over 100 employees worldwide with years of experience in bringing medical products successfully to market in the US, EU and Canada.

Our Services:

♦ Outsourcing
    • Document and Change Control
    • Training Records Management
    • Complaint Handling / Adverse Event Reporting (MDR, MDV, CMDR)
    • Supplier and Internal Audit Programs
    • Donor Eligibility Determination (U.S. Market Offering)
    • Validation Programs

♦ Consulting
    • Quality Systems Assessments
    • Compliance Remediation
    • Regulatory Submissions
         º 513(g)
         º Pre-IDE
         º IDE
         º Request for Designation (RFD) for Combination Products
         º 510(k)
         º PMA
         º Canadian License Applications
         º EU Technical Files / Technical Dossier
    • Quality System Development
    • Validation

Location:

Reglera (Israel) Ltd.
17 Ha-Tidhar Street, Ra'anana 43665, Israel