Certificates

MONDRAGON-Health-certificados

ISO 13485. Design, development and production of medical devices and components

ISO 13485:2016

Electrocardiogram monitoring services and defibrillators

ISO 13485: 2018

Quality Management Systems

ISO 13485: 2016

In vitro Diagnosis certificate for plastic components for third-party companies

CE Medical Devices. CLASE I, II. IIa, IIb

EC 1434 MDD 201-2019

Electrocardiogram monitoring services and defibrillators

EC 1434-MDD-322-2020

Electrocardiogram monitoring services and defibrillators

PCBC 1434 MDD 322-2020

EC 200521_97 09 0036 CP

EC Certificate

EC 201028_97 07 0034 CP

EC Production Quality Assurance Certificate

EC 201022_2018 11 0879 CT

EC Full Quality Assurance System Certificate

EC 201028_ CE 97 07 0035 CP

EC Certificate

Biotech Credentials

IQNet 2022

Storage and custody of temperature-sensitive drugs and custody and transportation of Biological Samples.

BPD 20803-0001 2021

Certificate of Compliance with Good Distribution Practice (GDP)

ER 0140-2022

Storage and custody of Thermolabile Drugs and custody and transportation of Biological Samples

ISO 9001

ISO 9001

Quality Management System Certificate

ISO 9001: 2015

Gestión Servicios Residenciales, S. COOP.

ISO 14001

ISO 14001: 2015

ISO 45001

ISO 45001: 2018

Workplace Health and Safety Management System

ISO 45001: 2018

Gestión Servicios Residenciales, S. COOP.

ISO 45001: 2018

Workplace Health and Safety Management System Certificate

ISO 50001

ISO 50001: 2018

Production of technical components precision injected in thermoplastic materials via injection and assembly of components

Otras certificaciones

Statutory Auditing

Gestión Servicios Residenciales, S. COOP.

Health Licence 4144-PS 2023

GA-2016/0266

Environmental Management System Certificate

ES 2016: 0001

Certificate of Conformity with Healthy Organisation Management System