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. (MDD 93/42/EC, ISO 13485)

Are you planing to become ISO 13485:2016 compliance ?

We can help you, contact us in the form below

Competence area

Certification ISO 13485, ISO 9001
Compliance MDD 93/42/EC, EU-GMP
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 and regulatory department
Driving changes in the organizations
Improvement and Process management
Creating and maintaining quality documentations
Support in Medical Device CE-marketing process

Experienced professionals in:

MDD 93/42/EC, ISO 13485, ISO 9001, ISO 14971, EN 62366, IEC 62304, EU-GMP, GLP, QSR, 21 CFR 820, 21 CFR part 11, and more.

Contact us for more information:

Therese Albinsson

email: info@medqtech.se

phone: + 46 (0) 70 58 60 200