Chuanghui Company successfully passed CE replacement audit

July 25, 2018Day to 27On the same day, TÜV SÜD experts conducted a renewal audit of the company's system certification and product certification. The scope of this review includes six categories of products that have passed the review, as well as new vertebroplasty system products.

This audit is still carried out according to the requirements of MDD (European Medical Device Directive), and the audit of the clinical evaluation part refers to EU MEDDEV 2.7.1 rev4(Clinical Evaluation of Medical Device Guidelines). Through rigorous and detailed inspection and verification of the company's R & D, quality, production, logistics, manpower, market and other aspects, based on objective evidence, the audit team believes that the company's quality system is effective and meets the requirements, and the company successfully passed the audit.

May 5, 2017Day, Official Journal of the European Union (Official Journal of the European Union) The EU Medical Device Regulation (MDR) was officially released. On May 25, 2017, the MDR officially entered into force, which marks the upgrade of the MDD Directive to MDR (EU Medical Device Regulation) in the future. TÜV SÜD's experts gave a brief overview of the requirements of the MDR regulation, and the company's management and the audit experts had more equal exchanges. Through the discussion, it is recognized that the new regulations put forward higher and more detailed requirements for manufacturing companies. The new MDD CE certification is only valid until 2020, after which all new devices must be MDR certified. In order to pass the MDR certification, the company must update the technical documents and processes as soon as possible during the transition period to meet the regulatory requirements.

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