Certificates & Compliance
Aidplast operates in regulated medical device markets where quality, safety, and regulatory compliance are fundamental requirements. Manufacturing activities are conducted under structured quality systems designed to ensure consistency, traceability, and audit readiness.
The production of Aidplast medical plasters and wound care products is supported by internationally recognized management and regulatory certifications, including:
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ISO 13485 – Quality Management System for Medical Devices
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ISO 9001 – Quality Management System
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CE Certification for Medical Devices (MDD compliant; MDR certification process ongoing)
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Free Sale Certificate
These certifications demonstrate Aidplast’s compliance with applicable European medical device regulatory requirements and support its presence in international markets.
Quality and regulatory processes are implemented throughout the product lifecycle—from raw material control and manufacturing to final inspection and documentation—ensuring that products meet defined performance and safety expectations.
Compliance is treated not as a formal requirement, but as an integral part of everyday manufacturing practice.
