Medical Device Software Validation and Verification Compliance Kit

Medical Device Software Validation and Verification Compliance Kit

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10 - 9999
May 2014
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GMPs make it perfectly clear: All working parts of any medical device must be verified and validated. Period.

But how this requirement applies to software components is still a little sketchy.

Don't take the chance of being hit with a 483 or warning letter.

Use this new compliance kit to develop a solid risk-based software validation plan that will pass any FDA inspection.

The FDA is cracking down on companies that don't carry out device software verification and validation, issuing an increasing number of 483s and warning letters to 1) manufacturers of medical devices with embedded software, and 2) manufacturers of software used as a device itself.

With this new compliance kit, you'll find out exactly what FDA inspectors are being trained to look for in terms of device software verification and validation. And you'll learn how:

  • To meet agency expectations, particularly what you need to document
  • To develop a risk-based software validation and verification plan that fits within your company’s overall validation plan
  • To make your plan flexible enough to apply to a variety of products with a range of risk profiles
  • To interpret and apply FDA guidances, GAMP 4/5, 21 CFR Part 11, ISO 14971, ICH Q9 and other applicable industry software validation models

And then you'll learn to set up an 11-step plan for device software validation and verification, including how to:

  1. Perform risk analysis
  2. Determine level of concern
  3. Describe the software
  4. Formulate requirements specifications
  5. Develop design specifications
  6. Create an architecture design chart
  7. Craft a software development environment summary document
  8. Document validation and verification testing
  9. Perform a traceability analysis
  10. Determine unresolved anomalies
  11. Maintain a log of revision and release numbers

You'll also find out what the FDA accepts as an appropriate documentation model … its expectation for your testing software, ERP software and more … and, when and how to use design qualification, installation qualification, operational qualification and performance qualification.

What will you find in The FDAnews Medical Device Software Validation and Verification Compliance Kit? An invaluable collection of consolidated material from the FDAnews training database, designed to help your company become fully compliant as quickly as possible. For one low price, you get:

  • FDAnews'  top selling report Implementing an 11-Step Plan for Device Software Validation and Verification. Fully up-to-date, this report spells out the FDA’s expectations for software validation in clear detail so you’ll pass even the toughest audit or inspection.
  • A two-hour CD recording of FDAnews' recent highly rated webinar, Device Software Validation and Verification. Veteran FDA consultant John Lincoln outlines the FDA's preferred 11-element documentation model for software validation and verification and how to apply it to different situations.
  • A complete package of reference regulations and guidance covering all the software validation requirements including: FDA guidance on premarket submission requirements for software contained in medical devices, guidance on specific requirements for wireless technology in medical devices, and code of federal regulation references addressing software validation.
  • An impressive 60-page presentation filled with the details on how to create and implement a software validation and verification plan.

Let's face it. Mastering software validation and verification is a time-consuming task. And it's frustrating when an employee you’ve trained leaves you to go to work for a competitor — and you have to start all over again.

But with The FDAnews Medical Device Software Validation and Verification Compliance Kit, you can train anyone who needs it now right in your own offices  and keep everyone up to date as staffing changes occur for one low price.

This report is largely based on information provided during a recent FDAnews webinar led by John Lincoln, a principal with J.E. Lincoln and Associates. Mr. Lincoln has nearly 20 years of experience as an FDA consultant.

He has previously held positions in manufacturing, engineering, QA, QAE and regulatory affairs, as well as director of R&D. Mr. Lincoln also writes a regular column for the Journal of Validation Technology.

  • Quality assurance managers
  • Regulatory affairs officers
  • Software developers
  • Software programmers
  • Documentation specialists
  • Software testers
  • R&D managers
  • Engineers
  • Production managers
  • Operations managers

Need Extra Copies?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Simply choose the quantity you wish to order the discount will be calculated automatically.

3-4 copies – 10%

5-6 copies – 15%

7-9 copies – 20%

10+ copies – 25%

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