T
As a first time poster, I've tried to do my homework and looked at many of the prior posts on this topic, but none really satisfied my questions, so here goes...
BACKGROUND:
We are a start-up medical device company (ortho implants, mainly 510k). We are creating a QMS which we hope will be both FDA and 13485 compliant, but at the same time will give enough detail to aid new employees (aka engineers fresh out of school or from other industries) in understanding the intent of the regs.
We know that Design Verification is providing obj. evidence that the Design Output meets Design Input.
We intend to use a "Design Characteristics Document" to capture the user requirements (generally subjective in nature) and translate this into a "Product Specification" to document the Design Input in engineering terms (with a measurable value, tolerance, and defined test method). This is a pretty simple concept for everyone to understand.
I am writing the Design Verification procedure and am trying to give explicit examples of verification activities. We intend to document the Design Output via a trace matrix that will tie the input (product specifications) to the output.
ASSUMPTION:
Engineering Prints are a design outputs.
Risk Analysis (FMEA in our case) is a design output.
QUESTIONS:
T
BACKGROUND:
We are a start-up medical device company (ortho implants, mainly 510k). We are creating a QMS which we hope will be both FDA and 13485 compliant, but at the same time will give enough detail to aid new employees (aka engineers fresh out of school or from other industries) in understanding the intent of the regs.
We know that Design Verification is providing obj. evidence that the Design Output meets Design Input.
We intend to use a "Design Characteristics Document" to capture the user requirements (generally subjective in nature) and translate this into a "Product Specification" to document the Design Input in engineering terms (with a measurable value, tolerance, and defined test method). This is a pretty simple concept for everyone to understand.
I am writing the Design Verification procedure and am trying to give explicit examples of verification activities. We intend to document the Design Output via a trace matrix that will tie the input (product specifications) to the output.
ASSUMPTION:
Engineering Prints are a design outputs.
Risk Analysis (FMEA in our case) is a design output.
QUESTIONS:
- What are other design outputs?
- Are engineering calculations used to justify part dimensions and tolerances, such as those typically documented in lab notebooks, considered verification activities? If so, how do you later tie them to the Desing Inputs?
- Is review and approval of an engineering print a Design Verification? (I am approving that dimensions, notes, etc., in the print are adequate to meet the product specification.)
- If I simply confirm that a part meets it's print (i.e. via First Article Inspection), can I claim that it's been verified?
- Are verification activities expected to be statistically significant? (I've heard of 1-3 samples being used for verification.)
- If I require verification protocols & reports as the sole means of performing verification activities am I being too prescriptive? (I envision a protocol calling for bench testing of a production ready part to the product specification)
- Does anyone have a practicle example of Design Verification in the orthopedic implant business (plates and screws)?
T