design verification

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    Sample size for design verification of variable in single use device

    Hi All, long time reader, first time poster. I am a mech. engineer, frequently involved in "bench testing"of medical devices. I have trauled through the forums many times over the last few years on sample size selection and never really get much wiser. I've asked as many colleagues as I can in...
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    Why is initial production units, lots, or batches, or their equivalents required for Design Validation?

    hi, according to 820.30(g),design validation should be performed on initial production units, lots, or batches, or their equivalents. what is the purpoe of this requirement? the design verfication do not have the same requirements. how to demostrate the equivalents can anybody help to clarify...
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    Deviation in Design verification

    Hi all I am in the Medical Device business and we are internally having a discussion regarding deviations in Design Verification tests. You can do Design Verification on prototype items but by that you also say that you have a risk of a deviation which is related to the manufacturing process...
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    Medical device manufacturer and component supplier miscommunication

    Have any of you come across this, and how do we prevent it? I work for a medical device manufacturer that buys custom components that are manufactured by an ISO 13485 certified component manufacturer. I just audited this supplier. The components they make for us are considered to be in the R&D...
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    Partial Design Validation and changes to a critical supplier

    We are a manufacture of a class II medical device and we changed our LED supplier for a device that treats wrinkles. Can I get away with a partial design validation to confirm the LED requirements for the specified application have been met? Or would I also need to do a partial verification?
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    Design Verification - Managing Changes

    Hello Folks, Wanted to know your opinion on the following scenario I am in the middle of a design verification and found our that there are two different issues 1. A test failed because the requirement was written wrongly, instead of raising an alarm at 10 seconds, it raised at 20 seconds -...
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    CE Mark Approval Design Verification and Validation Questions

    Hello all, I need a help regarding Design verification protocol Right now we are working on a product for CE approval. Our product have in-house manufactured and bought out CE approved parts, My questionis 1) While writing verification steps for the complex requirement of bought out parts...
  8. V

    Template / format for Device History File & Design Verification of transdermal patch

    Transdermal patches Transdermal patches are considered as devices (by US FDA) I am looking for templates/formats used in typical regulated environment, and for combination products, devices or drug+device combinations. any references would be of great help.:thanks:
  9. D

    Pre-Design Verification - Using Continuous / Variables Data

    Hi all! I've been so frustrated lately because I feel like I'm struggling with such a simple concept. I'm used to performing design verification by choosing statistical C/ R intervals based on our risk analyses (95/90 or 95/95 usually) then selecting an attribute sample plan to test (n = 29/...
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    Design Verification: "Difference" in Sample Size Calculations?

    Hi. I am a new quality engineering manager for a medical devices company. Previous experiences in medical devices R&D, project mgmt, and operations. I am trying to determine the sample size for the Design Verification test. We want to demonstrate that the surface roughness of a particular...
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    Form that will satisfy Design Review and Design Verification Requirements (7.3)

    I am trying to create a form that would satisfy design review and design verification. Does anyone have a form I can use? Also, any ideas how to document design validation
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    Sample Size justification for IEC 60601-1 Testing

    My company sends one device for 60601 testing. Our "user need" is that the device must be safe and we use the 60601 testing results to validate this. In terms of the FDA, all design verification and validation activities must include sample sizes that were determined using some statistical...
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    When to verify and when to validate Design Changes

    Hello! I am faced with the following situation. Our design change procedure states that changes have to verified and validated, if necessary. The decision for verifying or validating a design change is up to the design change team. Our procedure does not contain criteria, in what case a...
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    Product Development Lead Time with respect to APQP

    Can anybody give specific answer to my below questions w.r.t APQP? 1. In phase-2: what is the difference between design verification and design review? what should be verified and reviewed? Pls explain in detail specifically... 2. During Team feasibility commitment, apart from Cpk...
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    How to separate Product Design Review, Verification, and Validation Activities

    Product design 1.Review, 2.Verification, 3.Validation how to separate these operations? which activities to include in review, verification, validation?
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    Design and Development Outputs Approval, Verification and Validation

    Hi all, I can not understand the difference between approval of design and development outputs (clause 7.3.3) and design and development verification (clause 7.3.5). I think that one of the approval activities is the examination or assessment whether design and development outputs meet the...
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    Legacy Product - Do we need follow QSR 820? Design Verification and Validation

    we had a legacy product that finished design five years ago, and we got 510K two years ago. Recently we were noticed that FDA will audit our site this April. Now I have a concern for design control, do we need to finish design verification and validation activities etc like new NPI? Or we...
  18. S

    Acceptance Criteria at Design Verification

    Hi everybody, I am working in a company which manufactures grafts according to customers specifications. We have manufacturing and inspection processes for the products. Depending on the product, manufacturing processes perform very differently on a lot to lot basis. There might be a lot with...
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    Sample Size for Design Verification and Validation

    Recently, FDA auidted our site, they raised one question on sample size for design verification as follows: Specifically, procedures for identifying valid statistical techniques required for verifying the acceptability of product characteristics of a new design during design verification and...
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    Design Input/Output and Design V&V (Verification and Validation) Interpretations

    Hi, I was wondering is someone could help me interpret the following statements I once heard from a Design control expert: *********************************** Requirements = design input: broader than specifications and concern (are derived from) intended use(s) and user needs (testable...
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