Company Email Format Management

MedQtech AB

Medical Equipment Manufacturing Grebbestad, Västra Götalands Län, Se 5 employees

Employees: 5

medqtech.se LinkedIn

MedQtech AB Overview

Headquarters: Grebbestad, Västra Götalands Län, Se
Website: medqtech.se
Industry: Medical Equipment Manufacturing
Employees: 5
Founded: 2016
Company Email: Available in AeroLeads
NAICS: Medical Equipment and Supplies Manufacturing

Surgical and Medical Instrument Manufacturing

Surgical Appliance and Supplies Manufacturing

Keywords

Medical Device Industry Regulatory and Quality compliance ISO 13485 MDR (Medical Device Regulation ) 2017/745 IVD (In Vitro Diagnostic) EU Directive 98/79/EC IVDR (In Vitro Diagnostic regulations) 2017/746 MDD (Medical Device Directive) 93/42/EC EN 62366 ISO 14971 CAPA Training Regulatory specialist

About MedQtech AB

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