MENU
    1. Our Services
    2. Certification
    3. ISO 13485

ISO 13485

ISO 13485 is an international standard related to Quality Management System for Medical Device. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This applies not only to companies that construct, produce, and service medical devices, but also to organizations distributing and using them. ISO 13485 aims to increase the organization's reputation in the eyes of customers and authorities. ISO 13485 is not a product standard, it is a process standard which requires to comply with all relevant product and service oriented technical standards and regulations. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. It supports the reduction of unexpected risks with regard to the devices and enhances their management.

Benefits of ISO 13485 Certification:

  • Tranparency and clarity of internal processes
  • Minimize and manage risks
  • Improve performance quality
  • Time and cost savings
  • Emphasize competence

TÜV NORD Philippines

TUV NORD Philippines, Inc.
Unit 406-407 Common Goal Tower,
Finance cor. Industry Sts., Madrigal Business Park (MBP), Ayala-Alabang 1780 Muntinlupa City

+632 807-6317, 807-8446, 809-0509
Fax: +63 2 842 9256

phil@tuv-nord.com

Cookie Settings
We would like to adapt the information on this website and our available services to your needs. For this purpose we use so-called cookies. Please decide which types of cookies you accept when using our website. The types of cookies that we use are described under "Details". Further information can be found in our privacy policy declaration.
Show details