Regulatory Open Forum

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  • 1.  Design verification

    Posted 22-Nov-2019 10:22
    Hi everyone, 

    When a company sends design input requirements to a supplier, what is the design verification test here that the output meets input? Is it just looking at the specification document (e.g. a CAD drawing)? Is a technical datasheet a design output? In this case, how is this kind of DHF verification written? When you receive the output from the supplier (e.g. an assembled PCB), I assume this kind of test is not a DHF verification test, but more like an incoming inspection test, correct? which would fall more into a DMR category?  I would appreciate any insight on this.  

    Thank you.

    Karen Zhou

  • 2.  RE: Design verification

    Posted 22-Nov-2019 11:23
    Hi Karen,

    I am thinking it will require an "incoming inspection" or a "first article inspection" depending upon the supplier's audit record and the risk class of the part (critical / not critical part).


    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices

  • 3.  RE: Design verification

    Posted 22-Nov-2019 16:05

    In the common situation a company sends the design inputs to a supplier because the supplier is going to do the design. The contract designer, then sends back the design outputs, a drawing package. The contract may or may not include design verification or design validation. The company that does the design may not have manufacturing capability.

    In the situation you describe the CAD drawing is the design output. The design verification is the check that the CAD drawing correctly includes all of its applicable design inputs. In this case you do not need to make the product on the CAD drawing. The design verification is a report that demonstrates the design inputs are correct.

    The list of design inputs, the CAD drawing (design output), and verification report go into the DHF.

    Skipping over design validation, since it may not be linear, the next step is design transfer. If you decided to use an external supplier, then design transfer moves the CAD drawing and associated information to three places.
    It is under document control, 820.40.
    In purchasing it becomes part of the purchasing data for the supplier, 820.50(b).
    A Quality Engineer develops the information for receiving acceptance, 820.80(b) and puts it under document control 820.40.

    Since this is an outsourced process, production, ISO 13485:2016 requires a quality agreement which is also part of the 820.50(b) purchasing data.

    The supplier designs the production process using their internal methods to produce the product.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States