In recent years, significant changes have been made to the European Regulation on Medical Devices and In Vitro Diagnostic Medical Devices (IVDPD), changes that have meant an important qualitative leap for all the agents involved in the sector. With the entry into force of the new regulations, the Notified Bodies are demanding more training for workers.
That is why the Basque Health Cluster has launched the Expert Course in Regulatory 2.0, with the aim of providing the necessary knowledge and skills to face the new regulatory framework. The course began on October 27 and is scheduled to end on June 14 next year. It is made up of 9 independent modules, all of them related to the regulatory framework for medical devices. Last Friday, the “Regulatory Framework” module began, taught by Larraitz Añorga, CEO of BIOLAN HEALTH, in which she had the opportunity to address the requirements necessary to prepare the technical documentation of IVDPs.
At BIOLAN HEALTH we are always up to date with the latest developments in the sector, especially in the regulation of in vitro diagnostic technologies. The Regulatory Expert course has been a great opportunity for BIOLAN HEALTH, through Larraitz, to share the knowledge to the students of the course in a close and practical way.