PRRC trainer and coach. Strategic consultant for medical devices companies, managing strategic regulatory risks for Europe. Also acting as PRRC, deputy PRRC, and PRRC support service.
𝗛𝗼𝘄 𝗱𝗶𝘀𝗮𝗽𝗽𝗼𝗶𝗻𝘁𝗶𝗻𝗴... After spending months of hard work, the notified body completeness review of your documentation results in... nothing... However, I think my client may get over this slightly mellow response and celebrate passing this first hurdle. The next step consists of the assessment of the documentation. I wouldn't be surprised if that feedback is similarly mild. This challenge 'only' concerns a notified body opinion ( #NBOp ) according to #Article_117 for an integral drug-delivery device, but this process is new to this organization. It was a pleasure helping this excellent team creating a solid set of documentation.