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. All manufactures of medical equipment must live up the vital requirements in either MDD (Medical Device Directive), MDR replacing MDD, AIMDD (Active Implantable Medical Device Directive) or IVDD (In Vitro Diagnostic Directive). A certification according to the ISO 13485 standard allow you to create a structure living up to MDR, MDD, AIMDD and IVDD.

FOCUS AREAS OF THE NETWORK

Among other things we are going to discuss internal audits, post-marketing surveillance and design control linked to presentations from competent specialists - internal Bureau Veritas experts as well as specialists with expertise within 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-ORDINATORS

Lead Auditor

Valérie Viejo

She has extensive experience with the medico industry's regulatory requirements as well as production, quality control, research, development and use of medical equipment within the hospital system. Valérie has also held several seminars and courses within the standards of medical devices. In addition, she is an auditor on CE marking of medical devices, and has experience with CMDCAS, TCP and MRA.