Regulatory Open Forum

The question assumes that design verification requires making product. This naturally leads to the question of how many to make. The assumption doesn't hold, so the question of how many to make is not an issue.

QSR, in 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." Similarly, ISO 13485:2016, 7.3.6 says design verification ensures "that the design and development outputs have met the design and development

input requirements". Notice that neither requirement includes product testing.

The assumption is that design verification requires product testing, but it does not. Over time, the concepts of design verification and manufacturability have been conflated.

Design verification is a check that all of the design inputs are represented in the design outputs. This can, except in rare cases, be done by comparing documents. For example, if the design input requires a 10 foot long detachable power cord with a North American plug, the design output will be a purchasing specification. Design verification ensures that the item specified includes all of the attributes from the design input. I don't need to purchase 59 power cords for the design verification.

Similarly, for a manufactured part, the question is whether all the design inputs are correctly represented in the design output documents, typically drawings and specifications. Again, design verification compares the two sets of documents; it does not require making the parts represented in the design output. The standard approach is some kind of map from design input to design output to ensure full coverage. ISO 13485:2016, 7.3.2.e now requires documentation of "the methods to ensure traceability of design and development outputs to design and development inputs".

In terms of the design process the place you need a product is design validation. There, one product is sufficient.

The question assumes that design verification requires making product. This naturally leads to the question of how many to make. The assumption doesn't hold, so the question of how many to make is not an issue.

QSR, in 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." Similarly, ISO 13485:2016, 7.3.6 says design verification ensures "that the design and development outputs have met the design and development

input requirements". Notice that neither requirement includes product testing.

The assumption is that design verification requires product testing, but it does not. Over time, the concepts of design verification and manufacturability have been conflated.

Design verification is a check that all of the design inputs are represented in the design outputs. This can, except in rare cases, be done by comparing documents. For example, if the design input requires a 10 foot long detachable power cord with a North American plug, the design output will be a purchasing specification. Design verification ensures that the item specified includes all of the attributes from the design input. I don't need to purchase 59 power cords for the design verification.

Similarly, for a manufactured part, the question is whether all the design inputs are correctly represented in the design output documents, typically drawings and specifications. Again, design verification compares the two sets of documents; it does not require making the parts represented in the design output. The standard approach is some kind of map from design input to design output to ensure full coverage. ISO 13485:2016, 7.3.2.e now requires documentation of "the methods to ensure traceability of design and development outputs to design and development inputs".

In terms of the design process the place you need a product is design validation. There, one product is sufficient.

Ginger,

You have read the post correctly; I said that design verification does not require testing.

The problem is that many people have adopted the convention that design verification does require testing. My assertion is that this is a confusion between manufacturability and design verification. QSR, for example, 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." One can, in nearly all cases (I can't think of an exception), perform the confirmation without product testing or inspection.

Design output is, generally, drawings and specifications, not product. There is no regulatory requirement, that I know of, that requires making product as a design output. Product doesn't "appear" until after design transfer.

You say, "Very few inspectors or authorities would let this be enough." While that may be true it would be, in my opinion, an example of bad auditing, since this imposes expectations that are not regulatory requirements. This is particularly troublesome in an FDA Investigation because a 483 is an assertion of a violation of the law.

You say, "Typically I see representative prototype or final device performance testing as Design Verification". This is a common approach, but not required. The representative prototype or final device isn't required until design validation.

Returning to the initial post, if one follows the sample size convention cited, one representative prototype may not be sufficient; you could need 56!

My point is that I can confirm that the design output meets the design input requirements by comparing documents. There is no regulatory requirement to convert the design output into product to confirm that it meets the design input requirements.

If you know of such a requirement, please point it out to me.

The question assumes that design verification requires making product. This naturally leads to the question of how many to make. The assumption doesn't hold, so the question of how many to make is not an issue.

QSR, in 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." Similarly, ISO 13485:2016, 7.3.6 says design verification ensures "that the design and development outputs have met the design and development

input requirements". Notice that neither requirement includes product testing.

The assumption is that design verification requires product testing, but it does not. Over time, the concepts of design verification and manufacturability have been conflated.

Design verification is a check that all of the design inputs are represented in the design outputs. This can, except in rare cases, be done by comparing documents. For example, if the design input requires a 10 foot long detachable power cord with a North American plug, the design output will be a purchasing specification. Design verification ensures that the item specified includes all of the attributes from the design input. I don't need to purchase 59 power cords for the design verification.

Similarly, for a manufactured part, the question is whether all the design inputs are correctly represented in the design output documents, typically drawings and specifications. Again, design verification compares the two sets of documents; it does not require making the parts represented in the design output. The standard approach is some kind of map from design input to design output to ensure full coverage. ISO 13485:2016, 7.3.2.e now requires documentation of "the methods to ensure traceability of design and development outputs to design and development inputs".

In terms of the design process the place you need a product is design validation. There, one product is sufficient.

Ginger,

You have read the post correctly; I said that design verification does not require testing.

The problem is that many people have adopted the convention that design verification does require testing. My assertion is that this is a confusion between manufacturability and design verification. QSR, for example, 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." One can, in nearly all cases (I can't think of an exception), perform the confirmation without product testing or inspection.

Design output is, generally, drawings and specifications, not product. There is no regulatory requirement, that I know of, that requires making product as a design output. Product doesn't "appear" until after design transfer.

You say, "Very few inspectors or authorities would let this be enough." While that may be true it would be, in my opinion, an example of bad auditing, since this imposes expectations that are not regulatory requirements. This is particularly troublesome in an FDA Investigation because a 483 is an assertion of a violation of the law.

You say, "Typically I see representative prototype or final device performance testing as Design Verification". This is a common approach, but not required. The representative prototype or final device isn't required until design validation.

Returning to the initial post, if one follows the sample size convention cited, one representative prototype may not be sufficient; you could need 56!

My point is that I can confirm that the design output meets the design input requirements by comparing documents. There is no regulatory requirement to convert the design output into product to confirm that it meets the design input requirements.

If you know of such a requirement, please point it out to me.

The question assumes that design verification requires making product. This naturally leads to the question of how many to make. The assumption doesn't hold, so the question of how many to make is not an issue.

QSR, in 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." Similarly, ISO 13485:2016, 7.3.6 says design verification ensures "that the design and development outputs have met the design and development

input requirements". Notice that neither requirement includes product testing.

The assumption is that design verification requires product testing, but it does not. Over time, the concepts of design verification and manufacturability have been conflated.

Design verification is a check that all of the design inputs are represented in the design outputs. This can, except in rare cases, be done by comparing documents. For example, if the design input requires a 10 foot long detachable power cord with a North American plug, the design output will be a purchasing specification. Design verification ensures that the item specified includes all of the attributes from the design input. I don't need to purchase 59 power cords for the design verification.

Similarly, for a manufactured part, the question is whether all the design inputs are correctly represented in the design output documents, typically drawings and specifications. Again, design verification compares the two sets of documents; it does not require making the parts represented in the design output. The standard approach is some kind of map from design input to design output to ensure full coverage. ISO 13485:2016, 7.3.2.e now requires documentation of "the methods to ensure traceability of design and development outputs to design and development inputs".

In terms of the design process the place you need a product is design validation. There, one product is sufficient.

Ginger,

You have read the post correctly; I said that design verification does not require testing.

The problem is that many people have adopted the convention that design verification does require testing. My assertion is that this is a confusion between manufacturability and design verification. QSR, for example, 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." One can, in nearly all cases (I can't think of an exception), perform the confirmation without product testing or inspection.

Design output is, generally, drawings and specifications, not product. There is no regulatory requirement, that I know of, that requires making product as a design output. Product doesn't "appear" until after design transfer.

You say, "Very few inspectors or authorities would let this be enough." While that may be true it would be, in my opinion, an example of bad auditing, since this imposes expectations that are not regulatory requirements. This is particularly troublesome in an FDA Investigation because a 483 is an assertion of a violation of the law.

You say, "Typically I see representative prototype or final device performance testing as Design Verification". This is a common approach, but not required. The representative prototype or final device isn't required until design validation.

Returning to the initial post, if one follows the sample size convention cited, one representative prototype may not be sufficient; you could need 56!

My point is that I can confirm that the design output meets the design input requirements by comparing documents. There is no regulatory requirement to convert the design output into product to confirm that it meets the design input requirements.

If you know of such a requirement, please point it out to me.

The question assumes that design verification requires making product. This naturally leads to the question of how many to make. The assumption doesn't hold, so the question of how many to make is not an issue.

QSR, in 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." Similarly, ISO 13485:2016, 7.3.6 says design verification ensures "that the design and development outputs have met the design and development

input requirements". Notice that neither requirement includes product testing.

The assumption is that design verification requires product testing, but it does not. Over time, the concepts of design verification and manufacturability have been conflated.

Design verification is a check that all of the design inputs are represented in the design outputs. This can, except in rare cases, be done by comparing documents. For example, if the design input requires a 10 foot long detachable power cord with a North American plug, the design output will be a purchasing specification. Design verification ensures that the item specified includes all of the attributes from the design input. I don't need to purchase 59 power cords for the design verification.

Similarly, for a manufactured part, the question is whether all the design inputs are correctly represented in the design output documents, typically drawings and specifications. Again, design verification compares the two sets of documents; it does not require making the parts represented in the design output. The standard approach is some kind of map from design input to design output to ensure full coverage. ISO 13485:2016, 7.3.2.e now requires documentation of "the methods to ensure traceability of design and development outputs to design and development inputs".

In terms of the design process the place you need a product is design validation. There, one product is sufficient.

Ginger,

You have read the post correctly; I said that design verification does not require testing.

The problem is that many people have adopted the convention that design verification does require testing. My assertion is that this is a confusion between manufacturability and design verification. QSR, for example, 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." One can, in nearly all cases (I can't think of an exception), perform the confirmation without product testing or inspection.

Design output is, generally, drawings and specifications, not product. There is no regulatory requirement, that I know of, that requires making product as a design output. Product doesn't "appear" until after design transfer.

You say, "Very few inspectors or authorities would let this be enough." While that may be true it would be, in my opinion, an example of bad auditing, since this imposes expectations that are not regulatory requirements. This is particularly troublesome in an FDA Investigation because a 483 is an assertion of a violation of the law.

You say, "Typically I see representative prototype or final device performance testing as Design Verification". This is a common approach, but not required. The representative prototype or final device isn't required until design validation.

Returning to the initial post, if one follows the sample size convention cited, one representative prototype may not be sufficient; you could need 56!

My point is that I can confirm that the design output meets the design input requirements by comparing documents. There is no regulatory requirement to convert the design output into product to confirm that it meets the design input requirements.

If you know of such a requirement, please point it out to me.

The question assumes that design verification requires making product. This naturally leads to the question of how many to make. The assumption doesn't hold, so the question of how many to make is not an issue.

QSR, in 820.30(f), says, "Design verification shall confirm that the design output meets the design input requirements." Similarly, ISO 13485:2016, 7.3.6 says design verification ensures "that the design and development outputs have met the design and development

input requirements". Notice that neither requirement includes product testing.

The assumption is that design verification requires product testing, but it does not. Over time, the concepts of design verification and manufacturability have been conflated.

Design verification is a check that all of the design inputs are represented in the design outputs. This can, except in rare cases, be done by comparing documents. For example, if the design input requires a 10 foot long detachable power cord with a North American plug, the design output will be a purchasing specification. Design verification ensures that the item specified includes all of the attributes from the design input. I don't need to purchase 59 power cords for the design verification.

Similarly, for a manufactured part, the question is whether all the design inputs are correctly represented in the design output documents, typically drawings and specifications. Again, design verification compares the two sets of documents; it does not require making the parts represented in the design output. The standard approach is some kind of map from design input to design output to ensure full coverage. ISO 13485:2016, 7.3.2.e now requires documentation of "the methods to ensure traceability of design and development outputs to design and development inputs".

In terms of the design process the place you need a product is design validation. There, one product is sufficient.