Validation phase

Hi everyone,
I'm seeking your advice. We are a small R&D and manufacturing company of IVD testings certified under ISO13485. Our products fall under the 'research use only' category and are not regulated.

During the validation phase, which is part of our design and development process, I'm looking for guidance on determining the number of batches required for manufacturing and the number of samples per batch. Is there specific guidance or standards that I should refer to?

Additionally, considering that we operate as a research use only (RUO) company, is there any possibility to reduce the validation activities to a certain level? Your insights on this matter would be greatly appreciated.

Thanks.

I guess I'm a bit confused. If you're unregulated, what validation requirements are there? Do you plan to use the validation data for some ultimate submission sometime?

In terms of numbers (assuming an approach suitable for regulatory purposes ... which I'm not sure is the case here anyway), you have to have a statistically justified approach. I don't believe we have enough data to help you (and you need a statistical expert - which I'm not).