Regulatory Quality Service

Incra Med brings your resources with over 20 years experience in Management, Engineering, Quality, Regulatory and Supply Chain Control within multinational and indigenous companies. Dedicated exclusively to the medical device industry, our mission is to facilitate your Training, Regulatory and Quality Solutions. As part of this service we are available as a resource to the medical device sector. Our services include the following:

Regulatory Services

 

  • Consulting Advice and Strategies for Start Ups
  • 510(k) submissions
  • CE Mark Filing
  • Interim Management
  • Project Management
  • Design History File Preparation
  • Independent Reviewer
  • Risk Management

 

 

Quality Services

 

  • FDA Inspection Preparation
  • QSIT Type Inspections
  • FDA QSR Gap Analysis
  • Risk Management Systems and File Maintenance
  • Quality System Development
  • Supply Chain Audits
  • Internal Audits
  • Customised Training
  • Due Diligence Assessment

 

Contact Details

Incra Med LTD,
Unit 204 Business Innovation Centre,
NUI Galway,
Upper Newcastle,
Galway, Ireland.
Email: info@incramed.com
Phone: 087 2823571