Design Transfer of medical device

[Milas]

Is there a checklist which shows the deliverables required when a new design is from New Product Development to New Product Introduction ?

The industry is medical devices

Thanks
Sal

 

[indubioush]

Design transfer activities really depend on your internal processes, whether you are using a contract manufacturer, and other factors. Design transfer doesn't have to be a one-time thing. This list may help though:

Documentation Transferred to Production
Device Specifications
Software Specifications
Subassembly Specifications
Components, Raw Materials Specifications
Packaging Specifications
Labeling Specifications
Environment Specifications
Bill of Materials (BOM)
History Record (HR) Forms/Travelers
Manufacturing Work Instructions
QC Test Instructions and Forms
Tooling/Equipment Specifications
Specifications for Manufacturing Material

Design Transfer Tasks
Process Risk Analysis Performed and Documented
Equipment Installed and Qualified
Suppliers Evaluated and Approved
Product Monitoring Implemented
Process Monitoring Implemented
Supplier Monitoring Implemented
Completion, Approval, Release of DMR
Transfer Conclusion Documented

 

[Tidge]

Is there a checklist which shows the deliverables required when a new design is from New Product Development to New Product Introduction ?

Yes: The checklist will be in the design transfer plan for the device.

 

[Ed Panek]

Just FYI, if that's you, FDA audits will always audit CAPA and Complaints but...the one training record they are keenly interested in is "the person who has final product release authority." Have that person train on all this documentation

 

[Milas]

Thank you everyone, I have quick follow-up question.

If we take a "typical" medical device development cycle to include the following phases (proof of concept - Engineering Validation - Design Validation - Production validation and commercial build.

During which of the above phases, does the following take place:

Bench test/functional test?
Animal testing?
Clinical Testing?
Regulatory approval?
Any other key milestones?

Thanks

 

[Yvonne]

Thank you everyone, I have quick follow-up question.

If we take a "typical" medical device development cycle to include the following phases (proof of concept - Engineering Validation - Design Validation - Production validation and commercial build.

During which of the above phases, does the following take place:

Bench test/functional test?
Animal testing?
Clinical Testing?
Regulatory approval?
Any other key milestones?

Thanks

Hi Milas,

i) Bench Test/ Functional Test - It happen during design verification or design validation. We want to ensure that the design output meets the design input by conducting the functional test on the medical device.

ii) Animal Testing/ Clinical Testing - If you are referring to clinical investigation/ clinical trial on human, they would definitely belong to design validation

ii) Regulatory Approval - This process takes place after the process validation, whereby the product has been tested in the pilot run.

You can also refer to the US FDA Design Control for more detail information.

 

[Milas]

Design transfer activities really depend on your internal processes, whether you are using a contract manufacturer, and other factors. Design transfer doesn't have to be a one-time thing. This list may help though:

Documentation Transferred to Production
Device Specifications
Software Specifications
Subassembly Specifications
Components, Raw Materials Specifications
Packaging Specifications
Labeling Specifications
Environment Specifications
Bill of Materials (BOM)
History Record (HR) Forms/Travelers
Manufacturing Work Instructions
QC Test Instructions and Forms
Tooling/Equipment Specifications
Specifications for Manufacturing Material

Design Transfer Tasks
Process Risk Analysis Performed and Documented
Equipment Installed and Qualified
Suppliers Evaluated and Approved
Product Monitoring Implemented
Process Monitoring Implemented
Supplier Monitoring Implemented
Completion, Approval, Release of DMR
Transfer Conclusion Documented

Please can you elaborate on the sottware specfications which need to be transferred, is it just the software version or is there more to it than that ?

 

[indubioush]

Please can you elaborate on the software specifications which need to be transferred, is it just the software version or is there more to it than that ?

It is a requirements for producing the software for use in the medical device. It is everything that defines what it is and how it gets integrated to each system. The specific documentation can vary by company.

 

[yodon]

Two aspects for software in design transfer come to mind:

• How to ensure the correct version of the software is being loaded. What are the controls in place to ensure manufacturing (or whomever) had the right version
• How to ensure the software loaded wasn't corrupted (self-test, checksum)