Production & Quality

High-Standard Medical Textile Manufacturing

At Podima Medikal, we prioritize safety, hygiene, and durability in every stage of our medical textile production. Our facilities are designed according to international quality standards, ensuring full traceability from raw material selection to final packaging.

Raw Materials and Technology

We carefully select fabrics based on their intended medical use. Our SMS, SMMS, PP+PE, Triplex, and Biflex fabric options provide excellent liquid barrier and breathability performance. With ultrasonic stitching, overlock systems, and automated cutting technologies, we guarantee precision and durability at every production step.

Hygienic Manufacturing Environment

All production areas comply with cleanroom standards, maintaining controlled levels of temperature, humidity, and air purity. Sterile products undergo ETO (Ethylene Oxide) sterilization to ensure complete safety for medical use.

Quality Control & Traceability

Every production batch is subjected to comprehensive quality tests, including tensile strength, seam resistance, fluid barrier, and air permeability. Digital tracking systems ensure complete traceability throughout the entire manufacturing process.

For Podima Medikal, production is not just a process—it is a commitment to health and trust. Each product we manufacture meets the highest standards of safety and performance for global healthcare markets.

Global Compliance and MDR Certification

At Podima Medikal, all our processes—from production to distribution—are managed under international quality management systems. Our commitment to quality is not only documented by certifications but also driven by a philosophy of patient safety and sustainable excellence.

Our Certifications and Standards

• ISO 13485:2016 – Quality Management System for medical device manufacturing.
• ISO 9001:2015 – General quality management and continuous improvement.
• ISO 14001:2015 & ISO 45001:2018 – Environmental and occupational health & safety management.
• CE Certification (Conformité Européenne) – Compliance with EU technical requirements.
• EN 13795 – European standard for surgical drapes, gowns, and sterile textiles.
• TSE Certification – Compliance with Turkish national quality and safety standards.

MDR (Medical Device Regulation – EU 2017/745)

Podima Medikal is proudly certified under the European Union Medical Device Regulation (MDR 2017/745). This certification confirms that our products meet the highest requirements for safety, performance, and traceability within the EU market.

Our MDR compliance framework includes:

• Product risk management (ISO 14971)
• Clinical evaluation and technical documentation
• Labeling and Instructions for Use (IFU) compliance
• Post-market surveillance (PMS) and vigilance systems

With MDR certification, Podima Medikal products are legally recognized as medical devices in the European Union, ensuring global trust and reliability.

Quality Policy

At Podima Medikal, we believe that every product serving health must also represent trust. Therefore, we act with the philosophy of “not only controlling quality, but producing quality itself.”