Full Service CRO for Medical Device Companies

 
 

MedQ Consultants B.V., a company based in the Netherlands along the border with Belgium and Germany, is a full service international Contract Research Organization (CRO) providing strategic regulatory, quality and clinical trial support to the medical device industry.  MedQ is represented by its CEO’s, Robin J.M. Lucchesi and René Roncken.

MedQ provides a broad range of regulatory, quality, clinical and Authorized Representative services for the medical device industry in order to provide an economic practical approach in supporting your business through the life-cycle of the project.

The MedQ team is specialized and highly experienced in medical devices and qualified to provide MedQ Consultants B.V. services for Regulatory & Quality compliance, Clinical investigations and documentation, Quality Management Systems and Authorized Representative.

Clinical Strategy

clinicaltrial

Clinical Strategy

  • Clinical Strategy support
  • Trial management
  • Regulatory Submissions Ethics Committees and Authorities, Radiation Boards
  • Study Documentation Preparation/Review
  • Clinical Site Selection, Qualification, Initiation/ Monitoring/Close-out.
  • Support on essential (country specific) documentation
  • Safety Reporting
  • EDC system support
  • Clinical evaluation Report

Regulatory

Compliance

Regulatory

  • Advice on Regulatory strategy for obtaining CE-marking EU
  • Support compliance with (inter)national medical device Laws, Standards and guidelines
  • Pre-Clinical Data Compliance Review
  • Risk management review
  • Notified Body Support
  • Independent Clinical Site Audits ISO14155 and 21CFR Part11/ 50/812
  • Medical Device Market registration and Approval support
  • AR services
  • Vigilance and Safety reporting

Quality

QualityImage

Quality

  • QMS development ISO13485 /QSR/CMDCAS
  • QMS Support
  • QMS GAP Analysis
  • (ISO13485/21CFR part820)
  • Technical Documentation
  • Risk management