Certification:ISO9001,ISO13485, EC Directive 93/42/EEC (MDD) , EC Directive 98/79/EEC(IVDD), CMDCAS( Canada), JPAL ( [...] sgsgroup.com.cn sgsgroup.com.cn 认证:ISO 9001、ISO 13485、欧盟指令93/42/EEC(MDD)、欧盟指令98/79/EEC ...
ISO 13485 Certification Need of ISO 13485:2016 (MDQMS) The objective of MDQMS i.e. ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems. Medical Equipment’s are prone to any defect which causes ...
ISO 13485 Certification - Medical Device Quality Management System. Our expert team will guide you through the ISO 13485 certification process.
Certification Overview ISO 13485:2016 is a standard that defines the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry's quality system expectations and regulatory requirements, an organisation does not need...
Why Is an ISO 13485 Certification Important for Medical Devices? If you want to sell your products in other countries, then you need to be compliant with local laws and regulations. For example, most European countries require medical device manufacturers to obtain CE marking before they can ma...
Proteintech announces ISO 13485 Certification for Its HumanKine® Human Cell-expressed Cytokines and Growth FactorsROSEMONT, IL [06/01/20] – Proteintech Group, Inc, the benchmark in antibodies and proteins, announces completion of its ISO 13485 certification for medical devices. With this ...
ISO 13485 certification Request a quote and benefit from our additional resources to support your certification journey with BSI. Get started Standard Buy the BS EN ISO 13485 standard Get the BS EN ISO 13485 - Quality management system standard for medical devices or subscribe to get all the sta...
thereby instilling confidence in consumers and professionals. SGS offers UKAS-accredited ISO 13485 certification, recognized internationally, to help you gain regulatory authorization, medical device sales qualifications, and reduce the frequency of regulatory inspections and customer audits. ISO ...
最新版ISO13485:2016 医疗器械质量管理体系--用于法规的要求(英文版).pdf,INTERNATIONAL ISO STANDARD 13485 Third edition 2016-03-01 Medical devices — Quality management systems — Requirements for regulatory purposes Dispositifs médicaux — Systèmes de ma
Une certification ISO 13485 est un moyen de démontrer la conformité d’une organisation à la norme ISO 13485 créée par l’Organisation internationale de normalisation (ISO) pour l’industrie de la industrie dispositifs médicaux. Sa version actuelle est la norme ISO 13485:2016, dont la val...