Compliance
Regulatory Compliance & Quality Assurance
At AERS Medica, we prioritize patient safety and regulatory compliance across all our product lines. Our manufacturing processes and quality management systems are audited and certified to meet the highest international standards for medical devices.
Global Certifications
- ISO 13485:2016: Certified Quality Management System for Medical Devices.
- FDA Registration: All TENS and Infrared devices are FDA cleared/MDL registered for sale in the United States.
- CE MDR (Medical Device Regulation): Compliance with EU safety, health, and environmental protection requirements.
- TGA (Australia): Registered for clinical use in the Australian market.
Medical Disclaimer
The information provided on this website is for educational and informational purposes only. It is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
Product Safety & Testing
Our devices undergo rigorous testing for EMF safety, electrical biocompatibility, and clinical efficacy. We ensure that every product shipped from our facility meets the specific regulatory requirements of the destination country, including ASTM standards for pediatric wellness products where applicable.
For any compliance-related inquiries or to request certificate copies, please contact our quality department at info@aersmedica.com.