PutDownBoars
Registered
Hello all,
I'm working for a small med device company where my current project is to perform the packaging validation necessary to support a 510k submission. I performed a risk analysis of the packaging, and based on the risk I've determined that the sampling plan will need to show 95% confidence that 95% is conforming/pass the ISTA 2 Series: Partial Simulation Performance Tests.
To achieve the requirements of the above sampling plan, I've calculated that I need a sample size of n=59. 59 packages is a massive sample size! If I were packaging a prohibitively expensive device such as a robotic surgical unit, how could the FDA realistically expect me to test 59 packaged products without burning through all my company's cash? I've spoken to some colleagues at some of the larger established med device companies, and they've told me that they've been able to get good packaging validation results for their products with only 15 samples, though they've been unable to provide me with how they provided valid rationale for that smaller sample size.
I've heard of companies using 3 or 5 samples as the magic number for verification/validation, so I feel like I'm missing something here? I'd appreciate anyone who can provide input.
I'm working for a small med device company where my current project is to perform the packaging validation necessary to support a 510k submission. I performed a risk analysis of the packaging, and based on the risk I've determined that the sampling plan will need to show 95% confidence that 95% is conforming/pass the ISTA 2 Series: Partial Simulation Performance Tests.
To achieve the requirements of the above sampling plan, I've calculated that I need a sample size of n=59. 59 packages is a massive sample size! If I were packaging a prohibitively expensive device such as a robotic surgical unit, how could the FDA realistically expect me to test 59 packaged products without burning through all my company's cash? I've spoken to some colleagues at some of the larger established med device companies, and they've told me that they've been able to get good packaging validation results for their products with only 15 samples, though they've been unable to provide me with how they provided valid rationale for that smaller sample size.
I've heard of companies using 3 or 5 samples as the magic number for verification/validation, so I feel like I'm missing something here? I'd appreciate anyone who can provide input.