[{"data":1,"prerenderedAt":184},["ShallowReactive",2],{"content-quality-management-en":3},{"id":4,"title":5,"body":6,"description":175,"extension":176,"meta":177,"navigation":179,"path":180,"seo":181,"stem":182,"__hash__":183},"content\u002Fquality-management\u002Fquality-management.en.md","Quality Management Systems (QMS) for Medical Devices",{"type":7,"value":8,"toc":157},"minimark",[9,13,17,30,33,36,39,42,46,49,54,62,66,71,75,83,87,92,96,101,103,107,111,114,128,130,134,137,140,148,150,154],[10,11,5],"h2",{"id":12},"quality-management-systems-qms-for-medical-devices",[14,15,16],"p",{},"A Quality Management System (QMS) is a formalized system that documents:",[18,19,20,24,27],"ul",{},[21,22,23],"li",{},"Processes",[21,25,26],{},"Procedures",[21,28,29],{},"Responsibilities",[14,31,32],{},"All aimed at achieving policies and objectives that define the quality of a medical device.",[14,34,35],{},"A QMS helps coordinate and direct an organization’s activities to meet regulatory and customer requirements, while continuously improving effectiveness and efficiency.",[14,37,38],{},"We provide consulting and support for quality management systems for medical device companies across Europe and the United Kingdom.",[40,41],"hr",{},[10,43,45],{"id":44},"our-services","Our Services",[14,47,48],{},"Our QMS-related services include, but are not limited to:",[50,51,53],"h3",{"id":52},"implementation-improvement","Implementation & Improvement",[18,55,56,59],{},[21,57,58],{},"Implementation, audit, and improvement of ISO 9001 and ISO 13485 quality management systems",[21,60,61],{},"System updates and continuous improvement",[50,63,65],{"id":64},"additional-standards","Additional Standards",[18,67,68],{},[21,69,70],{},"Implementation, audit, and improvement of ISO 22716, BRC, and IFS standards",[50,72,74],{"id":73},"audit-preparation","Audit Preparation",[18,76,77,80],{},[21,78,79],{},"Preparation for certification audits",[21,81,82],{},"Support in resolving issues and non-conformities following audits or inspections",[50,84,86],{"id":85},"supplier-audits","Supplier Audits",[18,88,89],{},[21,90,91],{},"Qualification and auditing of suppliers",[50,93,95],{"id":94},"ivd-support","IVD Support",[18,97,98],{},[21,99,100],{},"Specialist support for manufacturers of in vitro diagnostic devices (IVDs)",[40,102],{},[10,104,106],{"id":105},"focus-on-iso-13485","Focus on ISO 13485",[50,108,110],{"id":109},"cost-of-implementation","Cost of Implementation",[14,112,113],{},"The cost of implementing an ISO 13485-compliant quality management system depends on several factors:",[18,115,116,119,122,125],{},[21,117,118],{},"Size of the organization (number of offices, branches, and employees)",[21,120,121],{},"Scope of the QMS (e.g., development, production, sales, support)",[21,123,124],{},"Existing quality systems (e.g., ISO 9001)",[21,126,127],{},"Level of management commitment and employee involvement",[40,129],{},[50,131,133],{"id":132},"timeline","Timeline",[14,135,136],{},"The time required to implement an ISO 13485-compliant system varies depending on the organization.",[14,138,139],{},"In general:",[18,141,142,145],{},[21,143,144],{},"Consulting support ranges from approximately 8 to 20 days",[21,146,147],{},"The overall process may take at least 6 months to reach certification",[40,149],{},[10,151,153],{"id":152},"our-approach","Our Approach",[14,155,156],{},"We support organizations throughout the entire QMS lifecycle — from initial assessment and system design to certification and continuous improvement — ensuring full compliance and long-term operational efficiency.",{"title":158,"searchDepth":159,"depth":159,"links":160},"",2,[161,162,170,174],{"id":12,"depth":159,"text":5},{"id":44,"depth":159,"text":45,"children":163},[164,166,167,168,169],{"id":52,"depth":165,"text":53},3,{"id":64,"depth":165,"text":65},{"id":73,"depth":165,"text":74},{"id":85,"depth":165,"text":86},{"id":94,"depth":165,"text":95},{"id":105,"depth":159,"text":106,"children":171},[172,173],{"id":109,"depth":165,"text":110},{"id":132,"depth":165,"text":133},{"id":152,"depth":159,"text":153},"Consultancy and implementation support for ISO 13485 and ISO 9001 quality management systems for medical device companies.","md",{"image":178},"\u002Fimages\u002Fqms.jpg",true,"\u002Fquality-management\u002Fquality-management.en",{"title":5,"description":175},"quality-management\u002Fquality-management.en","TM5rNJKlnxHa_AxvtHO370BAaru5tBCFhkwvNJ6yTRk",1775573784294]