Quality & Regulatory

Patient safety and clinical integrity drive everything we do. NerveAide operates a medical-grade quality system (ISO 13485) and follows EU MDR requirements—from risk management and clinical evaluation to post-market surveillance and vigilance. Our products are engineered for safety, reliability, and data protection, enabling clinicians and users to trust what they use every day.

What you’ll find here

• ISO 13485 QMS: design controls, supplier management, production & process controls, CAPA/NC handling, and continuous improvement.

• EU MDR compliance: device classification, GSPRs, risk management (ISO 14971), Clinical Evaluation (CER), PMS/PMCF, vigilance & trend reporting.

• UDI & EUDAMED: unique device identification and registration for transparency across the supply chain.

• Safety & EMC testing: conformity with applicable electrical safety and electromagnetic compatibility standards.

• Data privacy & security: privacy-by-design, secure app/cloud practices, and clear user consent for clinic-to-home use.

• Labeling & IFU: clear indications, contraindications, and step-by-step instructions to support correct use.

• Sustainability: durable hardware, repairability where possible, and responsible materials and packaging.