Medical Devices
At AiX, we leverage our extensive expertise in the design and execution of medical device manufacturing facilities. Our capabilities cover a broad spectrum of critical elements, including process design, cleanroom planning, equipment layout optimization, risk management (FMEA), and regulatory compliance aligned with global standards. We ensure precise control of environmental conditions, material flow and personnel movement to meet stringent quality and safety requirements.
Our commitment to excellence is reflected in our adherence to international regulatory frameworks such as US FDA, EU MDR, ISO standards, and more. From concept design and prototyping support to full-scale manufacturing, validation and compliance, we deliver end-to-end solutions across the entire lifecycle of medical device facilities.
We have experience in setting up the following facilities:
- Sterile Medical Device Manufacturing
- Non-Sterile Device Manufacturing
- Cleanroom Facilities (ISO Class 5–9)
- Implantable Devices Manufacturing
- Disposable & Single-Use Devices
- Diagnostic Devices (IVD)
- Electromechanical Medical Devices
- Packaging & Sterilization (ETO, Gamma, etc.)
- Assembly & Automation Lines
- Quality Control & Testing Laboratories
