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Quality

Our management system takes into account all the demands on and expectations faced by providers to the global pharmaceuticals and medical devices industries:

  • We are certified to the ISO 9001, ISO 13485 and ISO 14001 standards
  • We have CE mark certification under the Medical Device Directive (93/42/EEC) as amended by 2007/47/EEC
  • We comply with the Global Harmonization Task Force Guidelines
  • We have MSA accreditation
  • We build and maintain our cleanroom environments in accordance with ISO 14644