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Regulatory Requirements for Medical Device Calibration Programs

 
  March 24, 2010  
     
 


Complianceonline, Online Web Event
2010-03-26


This Regulatory Requirements webinar on Medical Device Calibration defines the concepts of accuracy and precision that define the measuring equipment’s requirements. It also explains the meaning of traceability. With these concepts, the webinar moves to an analysis of FDA requirements and ISO 13485 requirements.

Why Should You Attend:

Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement.

The presentation states with the regulatory requirements in the FDA’s QSR, ISO 13485, and ISO 9001. After analysis of these requirements, the presentation examines available guidance documents.

The FDA issued the Medical Device Quality Systems Manual to help companies implement the Quality system Regulation. Chapter 7 discusses the role of calibration systems in the QMS and helps define the regulatory expectations.

Learning Objectives:

  • Understand the requirements of the FDA’s QSR for calibration.
  • Understand the requirements of ISO 13485, ISO 9001, and their differences.
  • Distinguish between accuracy and precision and give an explanation of each term.
  • State the FDA’s expectations of a good calibration control system.

Areas Covered in the Seminar:

  • Understanding some metrology terms.
    • Accuracy
    • Precision
  • The concepts of traceability.
  • Calibration requirements of FDA QSR.
  • Chapter 7 of the FDA’s Quality Systems Manual.
  • Calibration requirements of ISO 13485 and ISO 9001.
  • Comparing the QSR and ISO systems.

 

 
 
Organized by: ComplianceOnline
Invited Speakers: Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
 
Deadline for Abstracts: Call contact
 
Registration:
Online Event
EVENT INFORMATION
Contact Admin, 
Phone: +1-650-620-3915
Fax number: +1-650-963-2556
E-mail: admin@complianceonline.com
 
   
 
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