Medical Device Software Validation

  Biological evaluation is an essential part of medical device right from the beginning and there are lot of advancement happening as the progress in technology happens and the experience that gained over a period in this field. It goes without saying that people got to be shielded from the potential biological risks that would arise from the utilization of medical devices, yet the range of biological hazards is wide and sophisticated. There is a standard existed BS EN ISO 10993-1-2009, and this was required to be followed as guideline however there were various separate method were used for actual evaluation depending on device type.   Recently EN ISO 10993-1:2020 – was published which covers the biological evaluation of medical devices within a risk management process as a part of the general evaluation and development of every medical device . This is mainly because international safety standard on medical device under risk management process also underwent massive revi...

 The healthcare and specifically medical device industry today is not what it had been just five years ago. Thanks to technology development and an innovative digital solutions All these developments are contributory from various fields like Information technology where software for managing devices accurately and data collection and its use by doctor remotely. Imagine the advantages of this technology during this corona pandemic where online consultation helped lot of patients where acquired data from device was sent to doctor for study, monitoring and additional diagnosis if required. Let us further examine the technology development and its benefit. 1.                                lot of Patient Data: data generated from measurement with software to convert them in desired pattern for doctor or nurses to take care of pati...