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
