Safety and Quality


Raw materials
We work with suppliers backed by more than 20 years of supply, always at the forefront of quality, reliability, innovation and development in the sector. Is there a better guarantee?
We carry out a rigorous analysis of our raw materials: from the selection and approval of our suppliers to the reception, control and verification that the materials comply with our quality standards.

Quality and Control in manufacturing
We carry out an exhaustive control in each of the production phases in clean rooms, this allows Lorca Marín to set more restrictive requirements than those established in the European Pharmacopoeia in order to achieve excellence in manufacturing. Our products, procedures and processes comply with the requirements of the current European Regulations on Medical Devices as well as all the specific applicable regulations.

Management Systems, Certification and Market Surveillance
All the medical devices we manufacture and distribute have the CE marking for medical devices. Our company is audited annually by the Notified Body of the Spanish Agency of Medicines and Medical Devices.
Lorca Marín has implemented and certified the ISO 13485:2016 Standard for Quality Management System for Medical Devices. We have a Management System based on this standard that integrates the following certifications:

Management System of
the quality of Medical Devices

GA-2008/0678

ER-164/1996

SST-0179/2010

RS-0009/2011

Technical assistance and after-sales service
Lorca Marín has a maintenance and after-sales technical assistance service for the devices it manufactures and distributes.
This allows us to provide a complete service during the entire life cycle of the products, guaranteeing minimum response times to possible incidents.