J
Hello Elsmar,
As always, thank you in advance for the assistance and time spent. Back at it again - this time I have another NC identified by my reviewer in the process of reviewing my technical documentation. Specifically, the reviewer identified the following NC:
Client has not submitted a Bill of material.
The requirement is listed as MDD93/42/EC Annex II section 3.2.
It has always been my understanding that a BOM is most applicable to devices that utilize computer or electronic circuitry, but not necessarily a medical device like the device we manufacture. The device I manufacture is akin to dental floss. We perform a chemical process on a raw material. Following the chemical treatment, the product is ready for use and prepared for sale. We are not necessarily combining multiple items into a single finished product.
I have gone through the MDD, and do not see any requirement to provide a BOM. Am I missing something significant? Thank you experts!
As always, thank you in advance for the assistance and time spent. Back at it again - this time I have another NC identified by my reviewer in the process of reviewing my technical documentation. Specifically, the reviewer identified the following NC:
Client has not submitted a Bill of material.
The requirement is listed as MDD93/42/EC Annex II section 3.2.
It has always been my understanding that a BOM is most applicable to devices that utilize computer or electronic circuitry, but not necessarily a medical device like the device we manufacture. The device I manufacture is akin to dental floss. We perform a chemical process on a raw material. Following the chemical treatment, the product is ready for use and prepared for sale. We are not necessarily combining multiple items into a single finished product.
I have gone through the MDD, and do not see any requirement to provide a BOM. Am I missing something significant? Thank you experts!