Regulatory Open Forum

1. Since our devices have been on the market around the world for over 10 years, post market surveillance data to indicate if there are failures for any of the design inputs. 
2. Scientific literature, guidelines etc. search, if any exist. Otherwise opinions from internal subject matter experts. 
3. Client acceptance / approval documents.
4. IQ/OQ/PQ as design verification.

You are making it too complicated. Just do the design verification and the design validation as you should have initially. The other things you list are not relevant.

Document the protocols and reports in the design history file. Each should have an indication that you performed them after release to production and are part of a correction.

These all fall under corrections of QMS nonconformances.

Also, open a corrective action to determine the cause of the nonconformance and eliminate it.

1. Since our devices have been on the market around the world for over 10 years, post market surveillance data to indicate if there are failures for any of the design inputs. 
2. Scientific literature, guidelines etc. search, if any exist. Otherwise opinions from internal subject matter experts. 
3. Client acceptance / approval documents.
4. IQ/OQ/PQ as design verification.

You are making it too complicated. Just do the design verification and the design validation as you should have initially. The other things you list are not relevant.

Document the protocols and reports in the design history file. Each should have an indication that you performed them after release to production and are part of a correction.

These all fall under corrections of QMS nonconformances.

Also, open a corrective action to determine the cause of the nonconformance and eliminate it.

1. Since our devices have been on the market around the world for over 10 years, post market surveillance data to indicate if there are failures for any of the design inputs. 
2. Scientific literature, guidelines etc. search, if any exist. Otherwise opinions from internal subject matter experts. 
3. Client acceptance / approval documents.
4. IQ/OQ/PQ as design verification.

You are making it too complicated. Just do the design verification and the design validation as you should have initially. The other things you list are not relevant.

Document the protocols and reports in the design history file. Each should have an indication that you performed them after release to production and are part of a correction.

These all fall under corrections of QMS nonconformances.

Also, open a corrective action to determine the cause of the nonconformance and eliminate it.

1. Since our devices have been on the market around the world for over 10 years, post market surveillance data to indicate if there are failures for any of the design inputs. 
2. Scientific literature, guidelines etc. search, if any exist. Otherwise opinions from internal subject matter experts. 
3. Client acceptance / approval documents.
4. IQ/OQ/PQ as design verification.

You are making it too complicated. Just do the design verification and the design validation as you should have initially. The other things you list are not relevant.

Document the protocols and reports in the design history file. Each should have an indication that you performed them after release to production and are part of a correction.

These all fall under corrections of QMS nonconformances.

Also, open a corrective action to determine the cause of the nonconformance and eliminate it.

1. Since our devices have been on the market around the world for over 10 years, post market surveillance data to indicate if there are failures for any of the design inputs. 
2. Scientific literature, guidelines etc. search, if any exist. Otherwise opinions from internal subject matter experts. 
3. Client acceptance / approval documents.
4. IQ/OQ/PQ as design verification.

While Dan alluded to it, but did not specifically mention there is no such thing as "DV&V". Design Verification is a separate and distinct activity from Design Validation. They have very different requirements and work with different aspects of the design with different focuses and different requirements. 

Design Validation is very different from Process Validation, which your statement seems to confuse. I recommend you refer to the "ISO Practical Guide-ISO 13485:2016 Medical devices" for a good discussion of the differences in the three topics. 

I might mention that successful Design Verification is an input to both Process Validation and Design Validation, so it should be completed first. Design Validation can use product that has been created during the PQ phase of Process Validation. 

Since it appears you are doing this from a retrospective perspective you must provide a rationale for why each of the three activities you are performing after the fact provides sufficient basis to keep existing distributed product on the market. You should also provide a rationale for product already on the market, if any discrepancies in the product are found during the three activities. 

You are making it too complicated. Just do the design verification and the design validation as you should have initially. The other things you list are not relevant.

Document the protocols and reports in the design history file. Each should have an indication that you performed them after release to production and are part of a correction.

These all fall under corrections of QMS nonconformances.

Also, open a corrective action to determine the cause of the nonconformance and eliminate it.

1. Since our devices have been on the market around the world for over 10 years, post market surveillance data to indicate if there are failures for any of the design inputs. 
2. Scientific literature, guidelines etc. search, if any exist. Otherwise opinions from internal subject matter experts. 
3. Client acceptance / approval documents.
4. IQ/OQ/PQ as design verification.

When discussion verification and validation I recommend using the appropriate adjective. For example, design verification, design validation, process validation, software validation, etc. This avoids a lot of confusion.

In this post, which I answer in more detail in another response, the topics are design verification and design validation only.

Bill is correct that DV&V doesn't exist, because it is really two different things. We see this "abuse of language" in many places. The common is CAPA. I have people tell me they will open a CAPA. My first question is whether they intended to conduct corrective action or preventive action. They are two different processes.

While Dan alluded to it, but did not specifically mention there is no such thing as "DV&V". Design Verification is a separate and distinct activity from Design Validation. They have very different requirements and work with different aspects of the design with different focuses and different requirements. 

Design Validation is very different from Process Validation, which your statement seems to confuse. I recommend you refer to the "ISO Practical Guide-ISO 13485:2016 Medical devices" for a good discussion of the differences in the three topics. 

I might mention that successful Design Verification is an input to both Process Validation and Design Validation, so it should be completed first. Design Validation can use product that has been created during the PQ phase of Process Validation. 

Since it appears you are doing this from a retrospective perspective you must provide a rationale for why each of the three activities you are performing after the fact provides sufficient basis to keep existing distributed product on the market. You should also provide a rationale for product already on the market, if any discrepancies in the product are found during the three activities. 

You are making it too complicated. Just do the design verification and the design validation as you should have initially. The other things you list are not relevant.

Document the protocols and reports in the design history file. Each should have an indication that you performed them after release to production and are part of a correction.

These all fall under corrections of QMS nonconformances.

Also, open a corrective action to determine the cause of the nonconformance and eliminate it.

1. Since our devices have been on the market around the world for over 10 years, post market surveillance data to indicate if there are failures for any of the design inputs. 
2. Scientific literature, guidelines etc. search, if any exist. Otherwise opinions from internal subject matter experts. 
3. Client acceptance / approval documents.
4. IQ/OQ/PQ as design verification.