MedQtech AB

medical devices

About

MedQtech AB is a consultant business within the medical device industry. Experienced professionals with high competence support and help customers in the fields of Quality and Regulatory compliance. AREA of expertise: Certification ISO 13485, ISO 9001 Compliance MDD 93/42/EC, IVDD 98/79/EC Facilitation of Risk Management, ISO 14971 Interna audits, supplier audits, self inspections Non-conformities and root cause analysis, CAPA Implementations as PMS, CAPA, Vigilance & recall processes Customized trainings Act as Resources within the Quality & Regulatory department Driving changes in the organizations Improvement and Process management Creating and maintaining quality documentations Support in Medical Device CE-marketing process

Technologies

OutlookMicrosoft Office 365Mobile FriendlyGoogle Tag ManagerWordPress.orgNginxreCAPTCHAAIIoTAndroid

Keywords

medical device industryregulatory & quality complianceiso 13485mdr 2017745ivd eu directive 9879ecivdr 2017746mdd 9342en 62366iso 14971capatrainingregulatory specialistquality management systemdocument controllead auditerprocess managementtechnical documentationqualityiec 62304iec 623661expertsmedical equipment manufacturingqms developmentmedqdoc eqmsiso 13485 templates

Location

40A Roerviksvaegen, Vaestra Goetaland County, Sweden, 457 95

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