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
Company’s Keywords:
mdd 9342ec, ivdr 2017746, purchase control, ivd eu directive 9879ec, internal audits, quality, iec 623661, quality management system, supplier audits, lead auditer, medical device quality technology, mdr 2017745, document control, iso 14971, iec 62304, en 62366, training, capa, medical device industry, regulatory specialist, process management, experts, iso 13485, technical documentation, regulatory & quality compliance
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