Prosthetic Limbs

Form: Above-knee and below-knee prostheses, Partial and full limb replacements, Custom-molded limbs for specific needs

Strength: Advanced materials, lightweight structures, multi-axis joints, myoelectric controls, customizable for activity level, age, and limb loss type, with FDA approval and high durability

Reference Brands: Ottobock, Össur, Hanger, Fillauer, Proteor

Category: Medical Devices

Prosthetic limbs sold in the EU and US are regulated to ensure safety, quality, and performance. In the US, FDA approval involves validation, safety testing, and GMP compliance, while in the EU, CE marking certifies conformity with Medical Device Regulation (MDR). Devices undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, reliable prosthetic limbs supporting mobility, injury recovery, and improved quality of life worldwide, benefiting both clinical and rehabilitation settings.