FIT West Corp.
  • additive Fertigungstechnologien, mass customization, additives Engineering, Medizintechnik
  • Medizintechnik
  • additives Design
  • additives Engineering
  • Spritzgusswerkzeugkuehhlung SkinFreeze
  • Additive Serienfertigung
Zertifizierung – Der Qualitätsanspruch bei FIT Production

Certified Excellence: EN 9100, EN ISO 13485, ISO 9001, Japanese Accreditation for Medical Devices

  • ISO 9001:2008
  • ISO 9100:2016
  • EN 9001
  • ISO 13485:2012

With more than 20 years of experience, FIT Production has perfected its production processes.

EN ISO 13485 represents the requirements of a comprehensive quality management system for the design and manufacture of medical devices such as medical implants. The guidelines of the Medical Device Directive within the European Union are fully accomplished. Additionally, our services and manufacturing processes are also compliant with FDA requirements.
[ Download: EN ISO 13485:2016 ]

EN 9100 is a widely adopted quality management standard for the aerospace industry, technically equivalent to American SAE AS 9100/9110/9120 standards. EN 9100 is issued by the Society of Automotive Engineers and the European Association of Aerospace Industries.
[ Download: EN 9100:2018 ]

EN ISO 9000 is a series of standards, developed and published by the International Organization for Standardization (ISO), that define, establish, and maintain a quality assurance system for manufacturing and service industries. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. Simply put: Certification to ISO 9001 reflects our continuous ambition to do everything to fully satisfy our customers.
[ Download : ISO 9001:2015 ]

Japanese Accreditation Certificate of foreign medical device manufacturer
FIT Production has been certified as a foreign medical devices manufacturer pursuant to Article 13-3 of the Japanese Pharmaceutical Affairs Act.
[ Download: Accreditation certificate of foreign medical device ]