Medical Device > Quality Systems

The FDA is raising their expectations for medical device manufacturers with regard to quality systems.  In fact, newly appointed FDA commissioner, Margaret Hamburg, made a comment to this effect in her first public address encouraging manufacturers to make signficant investments in their quality and compliance systems to assure public safety (view Maetrics™ commentary on this issue).  It is becoming abundantly clear that inefficient and obselete quality systems that have managed to keep companies afloat in the past are going to require urgent attention in order to keep manufacturers compliant and competitive in today's landscape.  The team at Maetrics has diverse, proven collective experience in addressing a full realm of quality systems inititiatives such as:   

  • Quality Systems audits/assessments, pre-certification audits,
  • Quality Systems implementations, process improvement, SOP development, work instruction and procedures development
  • ISO certification assistance for ISO 13485:2003
  • ISO 9001 and ISO 13485:2003 training programs
  • Batch Records documentation
  • Complaints, CAPA, Adverse Event, and MDR processes and systems
  • Device master record/technical files remediation

Here is a link to a case example of quality systems based projects Maetrics has done for medical manufacturers.

ISO 13485:2003 Audit and Transition Services

Medical device manufacturers can achieve substantial benefits in quality by transitioning to this new standard. ISO 13485:2003 provides a process approach to quality management that focuses on:

  • The need to consider processes in terms of added value
  • Obtaining process performance results
  • Improvement of processes based on objective measurement
  • Meeting customer requirements
  • Meeting regulatory requirements

We offer a full scope of services to help you implement this standard.

Contact Maetrics™ Today

Whatever your quality systems needs might be, you can trust Maetrics™ to utilize proven experience to acheive both your quality and business driven goals through our Lean Compliance System.  We would be happy to conduct a complimentary baseline assessment of your current quality systems initiatives and present effective courses of action.