QUALITY & COMPLIANCE

Our Certificates & Accreditations

Our manufacturing processes and medical products are developed under internationally recognized quality, safety, environmental, and medical device standards.

ISO
↗
9001:2015

Quality Management System

International standard for quality management systems, ensuring consistent processes and continuous improvement.

01
ISO
↗
45001:2018

Occupational Health & Safety

Occupational health and safety management systems designed to maintain safer and healthier workplaces.

02
ISO
↗
11140-1:2014

Chemical Indicators

Sterilization of health care products using internationally recognized chemical indicator requirements.

03
ISO
↗
11607-1:2019

Medical Device Packaging

Packaging requirements for terminally sterilized medical devices and sterile barrier systems.

04
ISO
↗
11607-2:2019

Packaging Process Validation

Requirements for validation and control of packaging processes for terminally sterilized medical devices.

05
ISO
↗
14001:2015

Environmental Management

Environmental management systems supporting responsible operations and environmental performance.

06
EU
↗
EUDAMED

EU Medical Device Registration

Registered in accordance with EU MDR 2017/745 and IVDR 2017/746 requirements.

08
OFFICIAL DOCUMENTATION

View Our Complete Certificates

Download the official AMS certificates and accreditation documentation.

DOWNLOAD CERTIFICATES PDF ↓