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 Details
- Employees
- 5
- Founded
- -
- Address
- Rörviksvägen 40a, Grebbestad,vastra Gotaland County 457 95,sweden
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- medqtech.se
- 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, Quality Management System, Document Control, Lead Auditer, Process Management, Technical Documentation, Quality, IEC 62304, IEC 62366-1, Experts.
- HQ
- Grebbestad, Vastra Gotaland County
Medqtech Ab Questions
Medqtech Ab's website is medqtech.se
Medqtech Ab's LinkedIn profile is https://se.linkedin.com/company/medqtech
Medqtech Ab has
5 employees.
View email and phone details for 5
employees at Medqtech Ab.
Medqtech Ab's industry is
Medical Equipment Manufacturing
Medqtech Ab's top competitors are
Medtech4health,
Medqdoc,
Srs - Scandinavian Regulatory Services Ab,
Aurevia Medtech Compliance (Formerly Qadvis),
Gba Key2compliance,
I3cglobal,
Emploify,
Mediteq,
Oscar Medtec Ab,
Primed Ab.
Medqtech Ab's categories are Medical Equipment Manufacturing
Medqtech Ab's founding year is 2016
