Certifications for Andromedic HyDeep 600WM advanced oncologic hyperthermia device

ISO 13485: Quality Excellence

UNI CEI EN ISO 13485 Quality Certification

The HyDeep 600WM mHT device proudly holds the ISO 13485 certification. This underscores our commitment to meticulous quality control throughout the entire lifecycle—from design and development to production, installation, and servicing.

It establishes a robust framework for patient safety and product excellence, meeting strict global regulatory requirements.

MDR CE Certification

The deep local hyperthermia device has successfully obtained the European Council CE certification under the new Medical Device Regulation (MDR).

The MDR is a more stringent regulation than its predecessor, ensuring greater patient safety and market transparency. Achieving this means the HyDeep 600WM RF hyperthermia device for cancer therapy has undergone rigorous evaluation for clinical performance and risk management.

GMP Compliance

Every HyDeep 600WM hyperthermia system is built in accordance with Good Manufacturing Practice (GMP) standards. This ensures that products are consistently produced and controlled according to quality standards.

Our KGMP Certificate confirms that all aspects of production—from materials to staff training—meet the highest benchmarks for reliability.

Korea MFDF Approval

Our advanced oncologic hyperthermia device is validated in accordance with the stringent standards set by the Korean Ministry of Food and Drug Safety (MFDF). This certification is crucial for ensuring specific national regulatory requirements are met for medical devices imported and used within South Korea.