CAPABILITIES

Regulatory Compliance

We have a company-wide commitment to quality and regulatory compliance.

Medimor’s facilities comply with internationally recognized standards for medical devices; as well as health and safety requirements. Medimor ensures compliance through its well-established Quality Management System and by implementing its Quality Management Policy. This ensures that all products are always manufactured using reliable, repeatable, and compliant processes.

Medimor is committed to maintaining a high standard of corporate responsibility to Environment, Health and Safety (EHS), which is integral to its corporate philosophy. We believe our products play a significant role in improving people’s lives.

ISO 14001:2015

Environmental Management Standard

ISO 13485:2016

Notified by Dekra. Medical Devices, Quality Management System

ISO 45001:2018

Clean room monitoring and controls

EU GMP

Europe good manufacturing practice

ISO 27001:2023

Information security, cybersecurity and privacy protection

IMC

GMP by the Israeli Ministry of Health ("Yakar") since 2018

FDA

FDA Registered site

FDA 21

FDA CFR21 PART 820