Assistance during inspections by the Certification Authority.
#Iso 13485 standard verification#
Thanks to many years of experience, the Thema staff assists its customers in the implementation of the Quality System for medical devices and in vitro diagnostic medical devices, in accordance with regulatory requirements, providing a complete and modular service including the following activities: Relying on expert consultants is a valid and effective possibility to reach the result in the best possible way, optimizing time and costs. The procedures to obtain the ISO 13485 certification are rather challenging, and they require considerable investment in resources and time.
#Iso 13485 standard how to#
How to obtain the ISO 13485 certification? Improve the company image with the consequentįurthermore, in the case of manufacturers of medical devices and in vitro diagnostic medical devices, the application of the ISO 13485:2016 standard gives to the state of the art the presumption of conformity of the quality system when assessing the requirements for affixing the EC marking by a Notified Body and it allows a direct and independent audit to prepare for any market surveillance activity carried out by the Ministry of Health.Achieve competitive advantage on the ground and globally.Optimize resources by improving risk and emergency management.Certify the production of safer and more effective.Demonstrate the compliance with the required standards and.The Quality Management System and the related certification ISO 13485:2016 offer several advantages to companies in the field of medical devices and in vitro diagnostic medical devices.Īny stage of the device’s life cycle, the certified ISO 13485 management The advantages of the certification ISO 13485 Suppliers of particular processes associated with the manufacture of medical devices (e.g.Companies providing services related to medical devices (installation, maintenance and repair).Enterprise that distribute and market medical products.Companies that design, manufacture and assemble medical devices and in vitro diagnostic medical devices.Medical devices (MD) manufacturers who want to prepare for the future regulatory obligations of MDR 2017/745 and subject to EC marking.In vitro diagnostic medical devices (IVD) manufacturers who want to prepare for the future regulatory obligations of IVDR 2017/746 and subject to EC marking.Companies producing third-party brand medical devices but which intend to start marketing the devices of their behalf in EU markets.But to whom exactly does ISO 13485:2016 apply? It can be stated that companies which decide to apply and certificate a Quality Management System for medical devices and IVD, in accordance with the ISO 13485, demonstrate the will to continuously improve the effectiveness of their processes and they attest to their abilities to market secure and effective devices worldwide. Which are regulations that will replace the current directives in the 2021 and
Quality system is a prerequisite for manufacturers, critical suppliers,Īuthorised representatives, importers and distributors as established in the MDRĪnd in the IVDR (EU) 2017/746 for in vitro diagnostic medical devices, Marking in accordance with European directives and having a conforming Indeed, the main objective of the ISO 13485 is to favour international harmonization of requirements for medical devices and IVD. Moreover, the ISO 13485 is increasingly in demand to be the starting point of the application of the international GMP. The ISO 13485 standard ensures consistency of design, development, production, installation and supply in such a way as to make IVD and medical devices safe during their use. ISO 13485: the best certification for medical and in vitro diagnostic medical devices The certification ISO 13485 “Medical Devices – Quality Management Systems” identifies a standard for the Quality Management System specific for companies in the medical sector that includes aspects of the ISO 9001 standard and specific requirements for medical devices and in vitro diagnostic medical devices sector.