Do you work for a organisation that designs, manufactures, installs or maintains medical devices? Then you'll experience 4 major benefits:
You guarantee that your medical devices meet all strict European safety and quality requirements.
Your products are CE marked and MDR 93/42/EEC compliant. The CE label proves that your product meets all European safety, health and environmental requirements.
Another big plus: the ISO 13485 quality standard creates clarity for both producers and buyers.
Finally, you protect your end consumer thanks to guaranteed security after sale.
The quality, conformity and safety of our equipment is essential. As IBA operates all over the world, our equipment must meet the requirements of the market authorities in different countries. International as well as local standards are an indispensable tool to ensure that we meet all those legal requirements.
CaterinaBrusasco
R&D Compliance Expert at IBA.
Are you a manufacturer of medical devices? Then it is interesting to obtain ISO 13485 certification.
Why?
Want to know more about certification? You can read all about it here.
Ensuring the quality and safety of your medical devices? You can easily do so by getting started with ISO 13485 on our standards platform. This gives you an instant and convenient overview of all the requirements for an effective quality management system.
Find the standards you are looking for here
Want to manage the quality of your medical devices even more? Then take a look at the other standards for the medical sector.
Find the standards you are looking for here