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 3. ISO 13485 – MEDICAL DEVICE QUALITY MANAGEMENT SYSTEMS


ISO 13485 – MEDICAL DEVICE QUALITY MANAGEMENT SYSTEMS

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🎤  Charles Paul       |  📅  October 04, 2022   |  🕒  11 AM Eastern Time US



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Why You Should Attend:

ISO 13485 is a standard and not a regulation.  In the US, it is vital to
understand the differences between a standard and a regulation to avoid serious
compliance failures.  That said, the standard is just that, a standard, and is
the standard of choice for medical device manufacturers as it pertains to their
quality management system.  Certification under this standard is essential to
the organization’s ability to conduct business in the various markets that
require conformity to this standard and compliance to its country’s regulations.

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DESCRIPTION:

ISO 13485 is the international quality management system standard for medical
devices.  The function of this standard is to “specify requirements for a
quality management system where an organization needs to demonstrate its ability
to provide medical devices and related services that consistently meet customer
and applicable regulatory requirements.”  The standard has its beginnings in ISO
9001 but as a standalone standard, it has evolved over the years through various
versions. 

We will begin this webinar by overviewing the quality management system concept
extended to both the QSR and the ISO standard to provide a solid and appropriate
background to the further discussion of the standard.

We will next discuss the overall intent and impact of ISO 13485 in terms of why
it is important and what it is intended to accomplish.

Once those basic concepts are overviewed the contents of the standard, and the
impact of the various revisions and their specific change focus up to and
including ISO 13485:2016.

We will spend some time discussing the differences between 21 CFR820 and the ISO
Standard to fully realize the concept of conformance versus compliance.

We will end this webinar by discussing the process of implementing your quality
system in conformance with the standard. 

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Areas Covered in the Session :

 * Overview/basic elements of the quality management system
 * Typical quality system elements
 * Key attributes of a functional quality system
 * QSR vs ISO Compliance
 * ISO 13485 content overview and evolution of revisions
 * Implementing your quality system in conformance with the standard



Who Should Attend:

 * Quality Assurance Departments
 * Quality Control Departments
 * Regulatory Affairs and Compliance Departments
 * Manufacturing Departments
 * Production Departments
 * Research & Development Departments
 * Engineering Departments
 * Operations Departments
 * Logistics and Supply Chain Departments
 * Service and Maintenance Departments









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Medical Device FDA ISO 13485
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