Foryou NPWT: Negative Pressure Wound Therapy by 4L Health

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  • Foryou Medical Electronics Passed the EU Unannounced Audit
  • 06/11/2014

  •         On Nov. 6th, 2014, Foryou Medical Electronics Passed the EU Unannounced Audit by TUV SUD and becomes the first and only NPWT manufacturer in China which passed EU Unannounced Audit.
             In 2014, unannounced audit becomes mandatory by EU Commission Recommendation 2013/473/EU on the audits and assessments performed by Notified Bodies in the field of Medical Devices. It should be carried out on all manufacturers of medical devices of all classes. As the name suggests, an unannounced audit wound take place without prior notice to the manufacturer at any time and the inspection would take place immediately with the auditor’s arrival. Most audits will last one day and involve a team of two or more auditors.
             Unannounced audits will comprise two elements: a sample check to ensure recent or current production is in conformity with the technical documentation, meets specifications and that critical components and materials are traceable; and an audit of the critical processes of the quality management system. Testing of the chosen samples would be required to establish conformity. It can be undertaken during the audit, or the Notified Body may take away samples for subsequent test.
            The quality of medical devices is bound tightly with patient's life and death. To ensure product quality, all colleagues paid great effort to maintain the R&D and production quality system to promote product safety and effectiveness. Hard work results in great harvest. In 2012, Foryou Medical Electronics became the first NPWT system manufacturer which achieved NPWT system CE certificate and EU R&D production quality management system certificate. In 2013, Foryou Medical Electronics became the first NPWT manufacturer which achieved approval (FDA 510k) of entering the US market and the first NPWT manufacturer which passed US FDA site audit. In 2014, Foryou Medical Electronics became the first and only NPWT manufacturer in China which passed EU Unannounced Audit.
            With 18 years of R&D and production experience in medical devices together with 28 years in electronics products, we are devoted to developing high cost-effective NPWT systems.
            FORYOU NPWT, FOR YOUR NPWT.

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