After several months of work, preparation and dedication, usMIMA S.L., the company that developed MOWOOT, the non-pharmacological and non-invasive solution for constipation, has passed the certification audits for Quality Management Systems according to ISO 13485.
This milestone adds to the recent achievement of CE certification as a class IIa medical device for MOWOOT, obtained last August. The certification according to ISO standards guarantees the effectiveness of the quality management system of usMIMA and the commitment to continuous improvement.
The ISO standards certify the quality management of companies and are a synonym for reliability. ISO 13485, in particular, refers to the quality management system applicable to medical devices. It is internationally recognized for medical equipment manufacturers and related services and its main objective is to establish a set of harmonized regulatory requirements for quality management systems in the medical devices sector.
Ensuring patient safety
Thanks to the implementation of a quality management system according to this standard, usMIMA S.L. demonstrates its ability to produce safe and effective medical devices, meeting the regulatory requirements as well as customer expectations.
An important element included in the ISO 13485 is risk management. Its goal is the timely detection of dangers that may arise directly from medical devices or indirectly from certain applied procedures and their elimination as early as in the development process or in the later stages of the product life.
“The ISO 13485 certification guarantees the safety of patients and facilitates the access of MOWOOT to the worldwide medical technology market,” says Markus Wilhelms, CEO of usMIMA.
The usMIMA S.L. team would like to thank the agency that has granted this certification, BSI (British Standards Institution) in England for their work. BSI has pioneered ISO standards for more than 100 years and currently is the market leader.