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ComplianceOnline Home > ComplianceOnline Standards > Medical Device and Healthcare Technology – Standards & Test Methods
 
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Medical Device and Healthcare Technology: Quality & Compliance Manuals, Checklists & more - ComplianceOnline.com

Medical Device and Healthcare Technology

ComplianceOnline is the largest resource on the web for latest checklists, templates, SOPs, master plans, procedures and application on standards and regulations across industries (FDA, SOX, ISO ,Medical Device, Pharma, Manufacturing, Construction, Environment, hitech).
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SEP Quality Series - FMEA
Slide presentation on FMEA - Failure Modes and Effect Analysis (23 slides)
Provider: Superfactory
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price: $40.00
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Superfactory Excellence Program - Cellular Manufacturing and
Slide presentation on Cellular Manufacturing and Plant Layouts (77 slides)
Provider: Superfactory
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price: $40.00
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Evidence Product Checklist for the FDA Document: “Guidance For Industry, FDA Reviewers and Compliance On Off-The-Shelf Software Use In Medical Devices”
As Amended by “Guidance for Industry, FDA Reviewers and Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software January 14, 2005
Author: Stan Magee
Format: Word® (To save money, click here for our PDF version)
Language: English
Provider: SEPT
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price: $299.00
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Evidence Product Checklist For FDA Guidance For The Content Of Premarket Submissions For Software Contained In Medical Devices
ISBN 0-9819522-4-0,ISBN 13 978-0-9819522-4-6
Author: Stan Magee
Format: Word® (To save money, click here for our PDF version)
Language: English
Provider: SEPT
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price: $299.00
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Evidence Product Checklist for IEC Standard 60601-1-4 edition 1.1 2000-04, IEC 60601-1-4: Medical Electrical Equipment Part 1: General Requirements for Safety. Part 4. - Programmable Electrical Medical Systems
Format: PDF (Click here for our easy-to-modify Word® formatted version)
Language: English
Provider: SEPT
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price: $149.00
 
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