La qualité
notre priorité
Quality is our priority
Legal affairs
Beldico SA designs, develops, manufactures, sterilises and markets its products as medical devices.
The regulatory affairs department at Beldico SA ensures that our medical devices comply with applicable laws, regulations and standards throughout their life cycle, from design to marketing and post-market.
Our medical devices comply with the applicable performance, safety and quality requirements, as required by European Regulation (EU) 2017/745.
We therefore maintain the requirements applicable to maintaining the validated status of our ethylene oxide sterilisation processes (EN ISO 11135) and gamma irradiation processes (EN ISO 11137-1 and EN ISO 11137-2), biocompatibility (EN ISO 10993-1) and any other standards or guidance documents applicable to our various types and classes of devices (I, Is or IIa).
The CE marking of our devices is also linked to the maintenance of our EN ISO 13485: 2016 quality system.
Quality
BELDICO SA is certified by SGS and complies with the requirements of international standards NF EN ISO 13485: 2016 relating to the design, manufacture and marketing of non-active and non-implantable medical devices.
ISO 13485 defines the requirements for a quality management system (QMS) specific to medical devices. The main objective is to ensure that the devices designed, manufactured and distributed are safe, effective and comply with applicable regulations.
The quality system implemented by Beldico complies with ISO 13485 and aims to:
- ensure control of the risks associated with medical devices,
- demonstrate regulatory compliance,
- ensure complete product traceability,
- improve customer/user satisfaction,
- maintain a clear framework for design, manufacture, storage and distribution.
