We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Medical Devices » Devicemaker’s Guide to Quality System Change Management

Other Options

PDF Edition

$397.00

PDF Edition - 3-4 Copies (10% Off)

$357.00

PDF Edition - 5-6 Copies (15% Off)

$337.00

PDF Edition - 7-9 Copies (20% Off)

$317.00

PDF Edition - 10+ Copies (25% Off)

$297.00
Devicemaker’s Guide to Quality System Change Management

Devicemaker’s Guide to Quality System Change Management

$397.00
Medical Devices

Product Details

If you’re involved in any aspect of quality management systems (QMS) for your medical device, you need a strong change management process in place to avoid change interaction, where one change type triggers another change type.

Since QMS runs throughout your organization, it’s difficult to make a change in one area without impacting another.

Devicemaker’s Guide to Quality System Change Management breaks down QMS into separate areas where change may occur — device design, manufacturing processes, documentation and regulatory requirements. It explains the relevant requirements in the FDA’s quality management system regulations, the upcoming EU-MDR and the international standard ISO 13485. And it includes a template you can use to make sure each change element is properly addressed.

The report lays out a six-step plan for implementing change in the most cohesive way:

  • Understand the difference between incremental change and step-shift change
  • Identify change triggers
  • Assess the business implications
  • Ensure traceability through the steps of the change process
  • Apply the process to specific change types
  • Understand the interactions in the change types

Ensure a consistent approach to your change management process and avoid problems associated with ad hoc methods. Order your copy today.

Who Will Benefit

Managers and supervisors of the following functions would benefit:

  • Design Engineering
  • Regulatory Affairs
  • Quality Management
  • Risk Management
  • Production

PDF

$397.00
Add to Cart

ISBN-13:
978-1-60430-133-5

Publication date:
June 2020

Page count:
30


Multi-user Access
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.


Our Guarantee
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing