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:

Quality

ISO 9001:2015

IAF Sector: 19B, 23F (Design, development, production and assistance of mobility aids)

 

Quality for Medical Device

ISO 13485:2016

(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.

Address

  • Via Pizzone 11/7
    84085 Mercato San Severino

Phone

  • +39 089 820 1504

Social

Email

  • info@pandhora.it

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