Abbreviated 510 k
Abbreviated 510 k The medical devices for which the 510 k or premarket notification is requir...
Risk Management Process – ISO 14971:2019
Risk Management Process – ISO 14971:2019 For the CE marking of the medical devices, ris...
CMR or Endocrine Disrupting Substances in the Medical Devices
CMR or Endocrine Disrupting Substances in the Medical Devices According to regulation no. (EC...
Medical Devices Incorporating Nano materials
Medical Devices Incorporating Nano materials According to EU directive 2011/696/EU, the defin...
Medical Device Composed of Substances
Medical Device Composed of Substances Medical devices composed of substances or combination o...
Critical Processes in the Medical Device Manufacturing
Critical Processes in the Medical Device Manufacturing The manufacturing of the medical devic...
Clinical Data of Medical Device
Clinical Data of Medical Device Clinical data is the information about the safety and perform...
Preclinical Data of Medical Device
Preclinical Data of Medical Device The preclinical testing of a medical device is conducted t...
Electromagnetic Compatibility of Medical Devices
Electromagnetic Compatibility of Medical Devices For active medical devices CE marking, it is...
FDA Presubmission
FDA Presubmission Pre-submission process is used by applicant to obtain feedback from FDA bef...