Medical Device Software Validation

  Software if present in medical device has very important role to play as it controls, executes actions and some time reads data and acts accordingly. This can be called brain of medical device. The importance of getting the software system verified and validated is mandatory as per regulatory requirement. Failure to fulfil verification and validation standards, ends up in a substandard product, the surest direction for disaster that can be of any magnitude. software system verification and validation failure is that the third most frequently cited violation for medical devices by the agency. Software system in medical devices is being perceives as fancy feature by many, however this makes complicated   interaction of several connecting devices more simpler and therefore   user friendly. Thus, importance of software is so important and apart from its complicity its user friendliness is prime motto of designer. Hence development of software and skill going inside i...

  If you develop yourself— medical devices, — then you’veseen the terms design validation and design verification (also referred to as V&V). Here we’ll try to find out   what these 2 activities are , the distinction between them, and share tips for understanding the foremost out of your efforts. It is clear that when you make any product, you always have user in mind. User can be medical professional or the patient. When you build up product considering design input, so you make design document and you write down all design input. Now next step is one need to check whether design output is matching with design input. This is design verification. This means one need to actually verify the output by using test methods and check quantifiable units whether they are matching with design input parameters. By simple verification it cannot be judged that product will work the way we have thought and that need to be proved that is design Validation. So even if design verifica...

  The medical device industry is presently facing massive reform like MDR (Medical device regulation) something never seen before. The massive changes will force many companies to do global reassessment and implement necessary changes to remain compliant. Even CE mark under MDD will also undergo major changes and your existing product will need re-certification. Clinical data and labelling also will need updating. UDI (Unique Device Identification) system is being established to track devices throughout the economic operator supply-chain. Serious incident reporting time has changed from 30 days to 15 days and all data will be centralised so everyone can access it. So, manufacturer has to be vigilant and quality of the product must be robust enough to take care of safety aspect. Conduct an audit Hopefully at this stage, your organization has already run a comprehensive audit to spot compliance gaps and confirm what changes need to be done Make internal product information...