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

Outlook Microsoft Office 365 Mobile Friendly Google Tag Manager WordPress.org Nginx reCAPTCHA AI IoT Android

Keywords

medical device industry regulatory & quality compliance iso 13485 mdr 2017 745 ivd eu directive 98 79 ec ivdr 2017 746 mdd 93 42 en 62366 iso 14971 capa training regulatory specialist quality management system document control lead auditer process management technical documentation quality iec 62304 iec 623661 experts medical equipment manufacturing qms development medqdoc eqms iso 13485 templates

Location

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

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