
Walking aids (crutches, walkers)
Form: Crutches: Underarm and forearm types, Walkers: Standard, rollator (with wheels), bariatric models In the United States:
Strength: Durable, adjustable height, ergonomic design, lightweight materials, suitable for various mobility needs
Reference Brands: Drive Medical, Medline, Hugo, Nova Medical, Invacare
Category: Medical Devices
Walking aids such as crutches and walkers are regulated in the EU and US, with dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP and MDR standards. In the US, FDA approval involves validation, safety, and performance testing, while in the EU, CE marking certifies conformity with medical device regulations. These devices undergo validation, stability testing, and audits, with detailed documentation including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to reliable, safe mobility aids supporting independence and safety across healthcare and veterinary applications worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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