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The QSE UPDATE

 

The QSE UPDATE is intended to provide information, discussion and commentary on current topics of interest to individuals working in the medical device and diagnostics industry. Please visit this site to view the latest update.

Comments or requests for additional information can be sent to QSE at rich@qsenet.com.

QSE UPDATE

QSE Announces a New Office Location on the West Coast

 

Quality Systems Engineering, Inc. (“QSE”) is celebrating 20 years in business this year, providing reliable quality systems and regulatory compliance consulting services to our clients in the medical device and diagnostic industries.  It is our pleasure to announce that QSE has now established a second business location in Southern California to better service our clients on the West Coast.  QSE now maintains offices both in the Naples, Florida area as well as in the Carlsbad, California area. 

 

Our business has been built in large measure on repeat business and referrals from many of our existing clients who have recognized the value and expertise of using our team of MD&DI industry veterans, each with more than 20 years of senior leadership experience in quality systems and regulatory compliance management. 

 

We provide professional consulting support services to the medical device and diagnostic industry in the following areas.

 

  • Quality systems design, implementation, metrics, training, mentoring, and support (all elements of the QS)
  • Quality system and regulatory compliance management services
  • Certified quality engineering support including; design validation and verification activities and process validation and verification activities
  • Quality system auditing including QSIT audits, mock FDA audits, due diligence audits, and supplier audits
  • FDA inspection readiness - evaluation, preparation, and training
  • FDA enforcement activity remediation (Warning Letter, consent decree, recalls, etc.)
  • ISO and CE Mark certification and international product registration (EU)
  • Regulatory affairs strategy and support        
  • Preparation and submission of pre-market submissions to FDA
  • New product development and business planning
  • Risk Management process
  • Quality system and regulatory compliance temporary management services
  • Training and mentoring

 

Please feel free to contact Rich at any time to discuss your business needs at 954.326.1287 or via e-mail at rich@qsenet.com.

 

 

 

 

 

 
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