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ISO 13485 – Medical Device Manufacturing

The ISO 13485 standard represents an international consensus on good management practices that can be used by an organization that designs, develops, builds, installs or services medical devices. The primary aim of the standard is to supply guidelines on what constitutes an effective business management system for a medical device company. The challenge is developing a management system that provides just the right amount of information to provide structure and good communication in your organization while helping you improve to stay competitive in today’s changing world.

 

What QPA can do to help you develop and implement ISO 13485:

  • Complete a gap analysis that identifies what you do and don’t already have in place
  • Work with your management team to identify how a well documented management system can be a tool to help run the company
  • Define goals and objectives appropriate to your organization
  • Work with your people to define the processes/methods that all activities should follow
  • Organize and document your processes and systems
  • Assist you in implementing new support processes
  • Develop methods to measure and monitor processes
  • Implement continuous improvement into your management system
  • Assist you in integrating this management system into others you may already have
  • Assist you in developing an internal auditor program
  • Help you hire a registrar and go through the certification process