At Innovant Medical, quality is an integral part of our operations. Our systems are designed to comply with globally recognized standards, ensuring that every product meets high levels of safety, performance, and reliability. From regulatory compliance to risk control and documentation, we deliver confidence at every stage of the manufacturing process.
We work in alignment with ISO 13485, EU MDR, and FDA 21 CFR 820 requirements. Our quality management system is structured to support traceability, structured workflows, and compliance for global markets.
We apply strict process controls, conduct thorough product inspections, and maintain detailed records for quality and risk management. Each product is verified against precise requirements to ensure consistent performance.
We maintain Device History Records, Device Master Records, and validation files that meet regulatory needs. These documents support audits and streamline approval processes across global healthcare markets.
12A, Jalan Perniagaan Vortex 5, Vortex Business Park, 14100, Simpang Ampat, Penang, Malaysia
