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Medical Device Validation Document Resources

This blog provides a list of medical device validation resources and explains how to create your own resource list.

medical device academy valdiation resources Medical Device Validation Document Resources

The first step to understanding how to conduct successful validations are always to read and re-read the requirements of the documents below:

  • 21 CFR 820.30(g)
  • 21 CFR 820.75
  • ISO 13485, Clause 7.3
  • ISO 13485, Clause 7.5.2

Unfortunately, we sometimes need to consult a reference guide that explains aspects of the requirements.

Max Sherman (http://bit.ly/MaxSherman) is finishing a new handbook on design and process validation that will be published through RAPS. The following is a list of resources for process and design validation that I am submitting for publication in the book. Many of these resources are free, and these are the resources I personally use to learn and teach principles of validation.

  1. GHTF/SG3/N99-10:2004 – Process Validation Guidance (http://bit.ly/N99-10)
  2. ISO 14969 – ISO Guidance document for ISO 13485 (http://bit.ly/iso14969)
  3. 13485 Plus – CSA Guidance document for ISO 13485 (http://bit.ly/13485Plus)
  4. AAMI The Quality System Compendium: Bundled Set of Textbook & CD (http://bit.ly/AAMI-Store)
  5. Preamble to the QSR (http://bit.ly/QSR-preamble)
  6. ICH Q2: Validation of Analytical Procedures: Text and Methodology (http://bit.ly/Q2-Analytical-Validation)
  7. FDA Guidance for Part 11: Electronic Records (http://bit.ly/Part11Guidance)
  8. FDA Guidance for Software Validation (http://bit.ly/FDA-Software-Validation)
  9. FAQs about Implementation of IEC 62304:2006 (http://bit.ly/Team-NB-IEC62304)

In addition to these resources, you may also need additional resources for design validation. Here are some examples of design validation resources I use in my design controls training “tool kit:”

  1. http://bit.ly/do-it-by-design
  2. http://bit.ly/DesignControlGuidance

As a regulatory affairs professional, it is critical to maintain a list of the most current standards and an organized list of links to those standards. I used to keep a list of favorites in my web browser for this purpose, but my database now exceeds the utility of “favorites.” Now, I use my own webpage for this purpose. You can do this yourself by creating a free WordPress blog, and having one of the webpages to the blog be specifically for the purpose of maintaining a list of Standards that are applicable. Here’s a link to my own webpage that I share: http://bit.ly/RA-Resources

 

 

Posted in: Validation

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FDA QSIT Inspection of Design Validation: Part I-Non-Software

qsit FDA QSIT Inspection of Design Validation: Part I Non Software This article reviews FDA QSIT inspection requirements of design validation, and is specific to devices which do not contain software.

In the FDA QSIT Manual (http://bit.ly/QSITManual), the word “validation” appears in the QSR 78 times. This exceeds the frequency of the word “verification,” “production,” “corrective” and the acronym “CAPA.” The word “validation” is almost as frequent as the word “management”–which appears 80 times in the QSIT Manual. The section of the QSIT Manual specific to design validation is pages 35-40.

The FDA selects only one product or product family when they are inspecting design controls. Therefore, if you keep track of which products have already been inspected by the agency, you can often predict the most likely product for the investigator to select during the next inspection. The number of MDRs and recalls reported will have an impact on the investigator’s selection. Class I devices are not selected.

The QSIT Manual instructs inspectors to verify that acceptance criteria were specified prior to conducting design validation activities, and that the validation meets the user needs and intended uses. There should also be no remaining discrepancies from the design validation. Inspectors must verify that all validation activities were performed using initial production devices or production equivalents. The last item to verify is that design changes were controlled–including performing design validation of the changes.

Risk Analysis

Risk analysis is seldom reviewed in great detail–except software risk analysis. However, when nonconforming product is reworked, it is required to review the adverse effects of rework. QSIT inspectors will expect you to document this review of risks. Investigators will also expect risks to be reviewed and updated in accordance with trend analysis of complaints, service reports and nonconformities. Finally, when companies assess the need to report recalls, the FDA expects to see a health hazard evaluation to be completed (http://bit.ly/HHE-Form). A detailed review of risk analysis is uncommon in QSIT inspections, but receives a greater emphasis in the review of CE marking applications.

Predetermined Acceptance Criteria

Investigators reviewing your design validation protocols will specifically look at the acceptance criteria for testing you perform. Investigators are looking for two things. First, were the acceptance criteria met without deviation? Second, was the protocol approved prior to knowing the results (i.e., was this a prospective design validation protocol?). In certain areas, there are also known risks associated with products that the investigators will look for. For example, in sterilization validation, the investigator will verify that the validation was performed to the most current version of the standard, and that the most common pitfalls of sterilization have been address by the validation. For example:

  • Have the most challenging devices been identified?
  • Has performance been validated at the maximum sterilization dose?

User Needs & Intended Uses are Met

In the area of user needs and intended uses, there are few problems with the initial launch of devices for the intended use. Problems typically arise when companies expand the intended use to new patient populations and new intended uses. When this occurs, there may be new user needs and risks that need to be evaluated. Therefore, the FDA periodically reviews claims made by companies in marketing communications to ensure that claims do not stray beyond the cleared intended use of the device. This will sometimes be identified as a 483 inspection observation, and in certain cases, the FDA will issue a warning letter to a company that continues to market a device for uncleared indications.

Initial Production Devices or Production Equivalents

When investigators review validation protocols and reports, the documentation must include traceability to the production lot(s) of the device. Investigators may even request a copy of the Device History Record (DHR) for the production lot used for validation. If a production lot is not used, then the design validation documentation must disclose how the product differs from production lots, and why the results are acceptable. The samples used should be subjected to final test/inspection requirements. If final test/inspection requirements are not yet established, samples should be retained, so that they can be inspected at a later date. Without this traceability, you may have to repeat your design validation with a production lot.

Validation of Design Changes

Far too many hours are wasted writing justifications for why re-validation is not required. I recommend that re-validation of design be performed for any design change if all three of the following criterion are not met:

  1. a sound scientific rationale can be provided with references
  2. the logic does not require a subject matter expert to understand it
  3. quantitative analysis is possible to analyze the risk impact

Many design validations require simulated use with a physician. Companies should obtain as much user feedback as possible before launching a device. Therefore, any re-validation that requires simulated use and user feedback should be a priority over writing a rationale for not conducting re-validation.

Posted in: FDA

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