In the world of aesthetic medicine, safety, consistency, and traceability are not optional they are essential. That’s why at Louna Aesthetics, all our injectable medical devices are developed and manufactured under the internationally recognized ISO 13485 quality management system.
ISO 13485 is the global standard for quality management systems specific to medical devices. It ensures that every stage from design and development to manufacturing, storage, and post-market surveillance is carried out under strict quality control procedures.
In aesthetic medicine, where devices are injected into the body, compliance with ISO 13485 is a strong marker of product reliability and patient safety
For medical professionals, working with ISO 13485–certified products means:
For patients, it means:
At Louna Aesthetics, we don’t just meet the standard, we make it part of our culture.
Our quality management system covers:
This structured approach ensures that every product from skinboosters to dermal fillers is made with the highest level of safety, efficacy, and consistency.
“Choosing ISO 13485 certified devices is not just about compliance, it’s about trust, safety, and responsibility. At Louna Aesthetics, we take this commitment seriously because your patients deserve the best”.