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The certification options under this IVD directive include Annex III, IV and VII comprising site audits and assessment of technical documentation. Our auditors who are nominated by notified bodies can do site audits and it will assess compliance to both EN ISO 13485:2003 and directive 98/79/EC together. Applicable Products . List A ISO 13485 is a quality standard based on the ISO 9001 standard with a focus on medical devices and compliance with this standard is requirement in most countries.

EN ISO 13485 Under 2006 får du kvalitetsstyrningssystemcertifiering ISO 9001 och ISO 13485. År 2007 får CE-certifiering. Under 2010 startar "Kinghawk" varumärkesbaserad konstruktion, och får CFDA / FSC (Free Sale Certificate, godkänt av China FDA). Certifiering: CE/ ISO13485 Pris: Förhandling. Skicka förfråganchatta nu Certifikat:CE/IS013485/CFDA.

•Physical testing must be conducted in China by CFDA certified testing centers.

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ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

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ISO 13485 is a voluntary standard and technically is not a required structure for a quality management system. Greentek ISO 13485 certificated Ag/AgCl electrode cap for direct use with Compumedics for PSG and EEG sleep analysis is the latest and most advanced cap available at this moment. This PSG and EEG Sleep EEG Cap combines the advantages of thin and light electrodes with a cable Cluster point at the top of the head, and the cap shell is totally made by soft materials for the best comfort of the ISO 13485 규격은 의료기기를 설계, 개발, 생산, 설치 및 부가서비스를 제공하는 조직의 시스템에 대한 요구사항을 규정한 규격으로서, 조직의 신뢰성이나 능력을 평가하기 위한 기준으로써 사용되고 있습니다.

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Inom EU krävs att produkten är CE-märkt (Conformité Canadian Medical Device Regulations. godkännandeprocesser hos CFDA (Kinesiska. Läkemedelsverket). Bolaget är ISO13485 certifierat av DNV. slutverifiering samt CE och CFDA registrering.

Product Detail Product SummaryIt is made from an especially precise process of high strength sapphire materal. Upgraded breakage resistance, esthetics, treatment capability and stability. We are currently implementing a QMS according to ISO 13485 for our software IVD product, that we are developing in-house.
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för de marknader som accepterar CE-märkning. ISO 13485 och lever upp till krav i internationell lagstiftning China Food and Drug Administration (CFDA). kännande av China Food and Drug Administration (CFDA). Inom EU krävs att produkten är CE-märkt (Conformité Canadian Medical Device Regulations.

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However, these “GMP requirements” (Notice N0. 218 Identical) are very similar to ISO 13485. Therefore, manufacturers usually submit the ISO 13485 certificate. However, the audit will review this certificate against the Chinese GMP requirements.