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Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel

Added by davidross759 on 2010-08-12

Conference Dates:

Start Date Start Date: 2010-08-24
Last Date Last Day: 2010-08-24
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2010-08-23

Conference Contact Info:

Contact Person Contact Person: Support
Email Email:
Address Address: Online Training Webinar, Wilmington, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

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 FDAs 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.
ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment, a document in the ISO 9000 family, specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met.
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