Peritoneal dialysis equipment

Form: Cyclers, Manual sets, PD solutions

Strength: High reliability, modular systems, validated for safety and efficacy

Reference Brands: Baxter (adria, stay-well), Fresenius, B. Braun

Category: Medical Devices

Peritoneal dialysis equipment in the EU and US are regulated to ensure safety, efficacy, and quality. In the US, FDA approval involves validation, safety testing, and GMP compliance. In the EU, CE marking certifies conformity with MDR standards. Devices undergo validation, performance 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 reliable, high-quality PD systems that support safe, effective peritoneal dialysis therapy worldwide, improving patient outcomes and supporting healthcare institutions' regulatory commitments.