Documentation, relevant training, relevant data review and so on.
Mecial Devicce Regulation 2017/745
Mecial Devicce Notification or Approval
Quality management system clinical evaluation and PMS, PSUR, PMCF, risk management and so on.
Relevant regulation, guidance, applicable standards and so on.
Harmonized, EN, IEC, ISO and so on
active device
wireless
Talking with CnA