Quality Management

At Qmed Consulting, the purpose of a Quality Management System is to ensure that the device will be developed, tested, manufactured and documented in accordance with general rules. The goal with the system is to keep traceability and ensure homogeneous batches and safe products.

Quality Management Services

Qmed Consulting can assist in:

  • establishing a quality system according to the rules for medical devices, containing required procedures, instructions and forms
  • monitoring and adjustment of your system (GAP-analysis)
  • conducting internal or vendor audits
  • preparing for external audits
  • training in MDD and ISO 13485

How we can help

Our strategic consultants have extensive knowledge and experience in all aspects related to quality management and quality assurance. We can support you in developing and implementing a quality management system in accordance with ISO 13485, ISO 14971, ISO 9001, GMP and applicable regulatory requirements.

Contact us and learn more about our Quality Management offerings.

Project Stages

Exploratory/Research Project Definition

What Happens:
  • Initial Market Research: Is there a Market?
  • Actual Potential Market Validation: Where and how to position the device?
  • Commerical Due Diligence: Provide commercial answers to investors
  • Project Risk Research
  • Regulatory and Clinical Research
  • Reimbursement Analysis

R&D:
  • Device Design Research

Documentation:
  • Initial Market Report
  • Commercial Due Diligence
  • Project Specification
  • Initial Regulatory Strategy
  • Reimbursement Analysis

- MILESTONE ACHIEVED -

Project Development

What Happens:
  • Device Concept Development

R&D:
  • Prototype Development
  • Material Evaluation

Documentation:
  • Design Requirements
  • Initial Clinical Literature Survey
  • Initial Material Survey
  • Regulatory and Clinical Strategy
  • Risk Analysis
  • Reimbursement Analysis

- MILESTONE ACHIEVED -

Design Verification and Freeze

What Happens:
  • Clinical Study set-up
  • Determine Clinical and Economic evidence needed
  • Risk Analysis
  • Final Product Development

Services:
  • Verification Tests
  • Biocompatibility Tests
  • Animal Tests
  • Prototype Production
  • Commercial Strategy

Documentation:
  • Verification and Validation Plan
  • Risk Analysis
  • Biological Evaluation
  • Clinical Evaluation
  • Device Specifications
  • Reimbursement Analysis
  • Budget Impact Model tools

- MILESTONE ACHIEVED -

Clinical Trial and Validation

What Happens:
  • Risk Analysis
  • Clinical Trial Start-up

Services:
  • Pilot Production
  • Clinical Trials
  • Product and Process Validation
  • Commercial Strategy

Documentation:
  • STED/Technical File
  • Validation Reports
  • Interim Clinical Trial Report
  • Reimbursement Analysis
  • Budget Impact Model Tools

- MILESTONE ACHIEVED -

Product Release and Market Surveillance

What Happens:
  • Regulatory Approval
  • Clinical Trial Follow-up
  • Marketing
  • Sales

Services:
  • CE Mark
  • Product Registration
  • Post Market Surveillance
  • Commercial Execution
  • Market Growth

Documentation:
  • Clinical Trial
  • Final Report
  • Vigilance Reports
  • Market Approval Letters
  • Budget Impact Model Tools

- MILESTONE ACHIEVED -