Tag Archives: CDRH

26Nov/18
quality

FDA’s Medical Device Enforcement and Quality Report

FDA Issues a Report on Increased Medical Device Inspections and Improved Compliance

The Report highlights:

  • Annual device inspections have increased 46% since 2007
  • The annual number of foreign device inspections have increased 243%  since 2007
  • The Agency is taking a targeted, risk-based enforcement approach to address specific device areas of concern.  Case studies mentioned in the report are:
    • Infusion Pumps
    • Automated External Defibrillators
    • Radiation Therapy Devices
  • From 2008 to 2007, 82% of firms corrected observed violations on follow-up inspections.
  • The FDA is also continuing to promote device quality through the Case for Quality initiative.

For related reading based on our involvement with the Case for Quality, please see:

FDA Driving Industry “Beyond Compliance” to Promote Manufacturing Quality

Is Compliance an Obstacle to Quality?

What is FDA Thinking? We Asked, They Answered!

The Case for Quality Voluntary Pilot Program

 Quality Metrics Program Update

06Mar/18
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CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

What’s In It For You?

By: Sandra K. Rodriguez, Market Analyst

On February 27th, the Medical Device Innovation Consortium (MDIC) provided a quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.  The program aims to build a culture of quality across the entire organization while producing measurable results including:

  • Reduce defects/re-work
  • Reduce costs
  • Accelerate time to market
  • Increase customer satisfaction

The pilot was announced in the Federal Register on December 28, 2017.  During the recent webinar, Kimberly Kaplan of CMMI Institute reviewed how the pilot program leverages the CMMI framework as the standard maturity model by which medical device organizations can measure their capability to produce high quality devices and improve patient safety.  To date, 13 organizations have enrolled in the pilot program.  She pointed out early indications show industry is having a hard time shifting from an inspection or audit mindset, to an appraisal approach – which is more conversational in nature. Continue reading