ISO 13485

Certifications for medical devices

Everywhere in the world, strict rules apply to medical devices and to companies concerned with their development, manufacture, sales and reconditioning. With its long years of experience as a certification body and notified body, TÜV NORD offers comprehensive service from one source - for safe access to national and international markets.

In detail, our range of services includes:

  • Conformity assessment procedures according to European Directives 93/42/EEC (active/non-active medical devices)
  • Certification of quality management systems for the European market according to EN ISO 13485
  • Safety tests in our own laboratory
  • Creation of expert’s reports 

Target groups for certification

This service is directed at national and internationally active

  • medical device manufacturers
  • sales organizations and logistics companies
  • specialists such as dental technicians, hearing aid manufacturers, orthopedic technicians, orthopedic shoe manufacturers, opticians, pharmacists, dentists and dental laboratories
  • service providers such as European medical representatives or contract sterilizing companies
  • service providers such as central sterilization locations in hospitals, doctors‘ surgeries or operating theatre units

Benefits of certification

Demonstrable fulfilment of the relevant legal requirements is a prerequisite for the marketing of medical devices. The TÜV NORD certificate, which is recognized and respected throughout the world, offers reliable proof that organizations fulfil their duty of care and adhere to high safety standards, which is an invaluable support when entering markets. The wide-ranging competence of TÜV NORD as regards the requirements of specific countries ensures smooth-running procedures; our worldwide network means that we are always near at hand, reacting rapidly to your needs.

Preconditions for certification

Depending on the conformity assessment procedure selected, the organization to be certified must either have established an effective quality management system or must fulfil the technical prerequisites for a product inspection. Please refer to our comprehensive brochure regarding possible conformity assessment procedures for different product classes for more detailed information.

Our know-how for your success

TÜV NORD is a well-established and reliable partner for inspection and certification services throughout the world. Our experts and auditors have extensive knowledge based on experience and are in general permanently employed by TÜV NORD. This guarantees independence and neutrality, and also means that we can offer continuity in supporting our clients. The benefit to you is clear: our auditors accompany and support the development of your company and provide you with objective feedback.

Please contact us

PT TÜV NORD Indonesia Head Office:

Arkadia Green Park, Tower F 6th Floor, Suite 602-604, Jl. TB. Simatupang Kav.88, Kebagusan, Pasar Minggu, Jakarta Selatan 12520

Ellys SimamoraGeneral Manager Operation
Asia Project Manager for Medical Internasional