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

MedQtech AB

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