Quality & Regulatory

The medical devices marketed by PEROUSE MEDICAL are designed, manufactured and distributed in keeping with the international regulatory requirements to allow access to markets worldwide.
The Quality Management System of PEROUSE MEDICAL meets the requirements of ISO 13485 standard as well as other international applicable standards in order to supply worldwide medical market:

  • NF EN ISO 13485
  • NF EN ISO 9001
  • Directive 93/42/CEE amended by 2007/47/CE
  • QSR (21CFR part 820) (USA)
  • JPAL MHLW ordinance N°169 (Japan)
  • Regulation 722/2012
  • SFDA (China)
  • RDC 16 (Brazil)
  • RIM Canada – DORS/98-282
  • Requirements of the Ministry of Health: Australia and Taiwan