A Choice of Quality
Pandhora S.r.l. is certified by Bureau Veritas ( an international certification body) in compliance with the regulatory obligations established by Regulation 745/17 (MDR) for the production and sale of our products with the CE mark, in the following fields:
IAF Sector: 19B, 23F (Design, development, production and assistance of mobility aids)
Quality for Medical Device
(Design, development, production, assistance of mobility aids)
Purpose of the certifications
ISO 9001 certification:
- Helps organizations develop and improve their performance, as well as demonstrate high levels of service quality.
- It offers greater visibility and transparency towards the reference markets and is often required as a prerequisite for tenders.
- Increases the ability to meet the needs and expectations of its customers through knowledge and control of the company.
ISO 13485 certification – Medical devices – Quality management systems:
- Face the development, implementation and maintenance of a quality management system for manufacturers and suppliers of medical devices.
- Provides a presumption of conformity with the essential requirements of important European directives, (eg: EU Directive on medical devices (93/42 / EEC and subsequent amendments); it also replaces proof of compliance with quality systems regulations (QSR) in the United States.
Via Pizzone 11/7
84085 Mercato San Severino
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