Quality and Regulation

Your Trusted Path to Full Global Regulatory Compliance

ISO 14001:2015

Environmental Management Standard

ISO 13485:2016

Medical Devices, Quality Management System

ISO 45001:2018

Occupational health and safety management system

AS 9100

Aerospace management systems

ISO 27001:2022

Information security, cybersecurity and privacy protection

FDA

FDA Registered site

FDA 21

FDA CFR21 PART 820

ISO 17025

Competence, impartiality, and consistent operation of testing and calibration laboratories

Quality and Regulatory Compliance

Medimor delivers world-class medical device manufacturing backed by a robust ISO 13485:2016 certified Quality Management System (QMS). We integrate Environment, Health, and Safety (EHS) into our core philosophy to improve lives through reliable medical solutions.

Process & Methods: The Core of Quality

Risk Management: We apply ISO 14971 standards across the entire product lifecycle, utilizing PFMEA to proactively mitigate risks
Continuous Improvement: Data-driven quality is our standard. We leverage CAPA, Statistical Process Control (SPC), and KPI tracking to ensure measurable excellence
Supplier Control: We ensure supply chain integrity through the rigorous qualification, auditing, and continuous performance monitoring of all critical suppliers