In Reply to Parent Post by Ronen E
Hello and welcome to the Cove
You may be right. Talk to the prospective NB(s). They may want to look at more than the class III device design dossier, depending on their policies, the specific NB you currently work with and other factors.
I'm in a similar situation, requiring a CE mark and already have ISO 13485 from another NB. The new NB is including full quality system and supplier audit as if I didn't have ISO 13485 certificate.
Shouldn't the notified body presume that quality systems which implement the relevant harmonized standards (EN ISO 13485:2012) conform to the requirements (MDD 93/42/EC item 3.3 and Blue Code item 5.1.6)? Although the certificate is issued as ISO 13485:2003 (not harmonized)?
"3.3. The notified body must audit the quality system to determine whether it
meets the requirements referred to in Section 3.2. It must presume that
quality systems which implement the relevant harmonized standards
conform to these requirements."