Our company recently purchased Advisera’s package of ISO 13485 templates for implementation in our company as we are starting producing class I medical devices (surgical gowns) to supply the Portuguese market as soon as possible.
I’m aware you provide a meeting to discuss doubts about the templates provided, but at the moment I’m in a hurry to solve an issue regarding the lot number coding and I didn’t find any information about that in the package purchased.
Is there any template to help us code the lot/batch number of a medical device or mandatory information that we should include in that code? We want to allocate that code automatically, but we don’t know what requirements to demand from the automatic batch number allocation.
Would you kindly help me with this matter?