Network: Medical udstyr

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Inspiration, idea exchange and professional sparring are key words in Bureau Veritas’ networks.

The actors in the medical industry increasingly face new challenges. In this network, you will meet others who face the same challenges as you and hear experts’ opinion within the area.

Development, production and marketing of medical equipment are subject to various legal requirements. Requirements increase that subsuppliers for the medical industry must prepare technical documentation for the parts they manufacture.

As of May 26 2021, manufacturers of medical devices must comply with the Essential Requirements, the Pharmacology system requirements and the quality management system requirements from the Medical Devices Regulation 2017/745. Manufacturers of in-vitro diagnostic medical device IVDD (In-Vitro Diagnostic Directive) must meet the requirements in the In-Vitro Diagnostic Regulation 2017/746. An accredited certification according to the ISO 13485 standard makes it possible to create a structure living up to the quality management system requirements in MDR and IVDR.

FOCUS AREAS OF THE NETWORK

In the Medical Network group, we have earlier discussed for instance internal audits, post-marked surveillance, MDR/IVDR structure, MDR/IVDR risks, UDI, supplier inspections and design control linked to presentations by competent professionals as well as internal Bureau Veritas specialists with expertise in the relevant areas.

In addition to the annual meetings, members get access to a closed forum in which they share all information.

DO YOU WISH TO JOIN US?

The price of this network is DKK 7.000 annually.

CO-ORDINATOR

Lead Auditor

Valérie Viejo

Lead Auditor, Valérie Viejo is the coordinator of the network group. She has experience with regulatory requirements, production, quality control, research, development and the use of medical devices within the medical device industry and hospitals.

Furthermore, Valérie Viejo has held several seminars and courses regarding standards for medical devices. She is also auditor for EN ISO 13485, CE marking of medical devices and has experience with other regulations within cosmetics, the pharmaceutical industry and health Care.