CECMED: Approved the national standard ISO ISO 13485: 2018. Medical equipment and devices. Quality Management Systems. Requirements for regulatory purposes.
The National Standardization Office (ONN) has just approved the national standard ISO ISO 13485: 2018. Medical equipment and devices. Quality Management Systems. Requirements for regulatory purposes.
This is a result of the work done by the specialists of the Department of Equipment and Medical Devices since 2016 when the international standard was approved. Multiple actions framed in a national research project were carried out, ranging from the study of new requirements, comparison with previous editions of the standard, training to manufacturers, importers, distributors and suppliers of medical equipment and devices, the updating of the regulatory requirements for quality management systems, and the preparation and presentation to the Technical Committee for Standardization # 11 of medical equipment of the draft of the new Cuban standard.