Softhale certified to ISO 13485
Softhale successfully achieved certification for its quality management system for medical devices in July 2021.
ISO 13485 is the medical industry’s optimal, internationally agreed, medical device standard. It ensures that medical devices meet the proper regulatory compliance laws and customer needs. Softhale successfully completed its first surveillance audit on ISO 13485 on March 7th, 2022, so the license will be retained.