Our company manufactures 1st risk class medical devices. For the moment we are improving our QMS in accordance with requirements of the new version of the standard. Especially we are wondering what should be considered as validation and verification of design and development. For example, we want to modify our existing device due to a request from a doctor or just add in our range of products something similar from competitors. Please give some examples of documents for this. Thanks!
Validation of design and development means to ensure that that improvement made to the existing device will not affect the safety and performance of the intended use of the original device. Simply to say, the process/ improvement must be reproducible to yield a consistent result. Example of such a document could be a validation plan or validation protocol. Verification of design and development would mean that the steps taken to achieve the improvement are followed strictly in order to produce the same medical device as per intended. Example of such a document could be a checklist of specifications totally against the initial design and the actual design prototype.
For examples of a document, you may refer to the following materials:
Hi, need advise on DHF. previously, the company is not ISO 13485 certified. but there are design activites that was done.. now that we need the DHF, but the documents /records are not available. What is the best way to deal with it? Can we open a CAPA and document that DHF not available and create a DHF for the product now? But how do we document the dates for the DHF> ? Etc the design plan, input for the activities will be way before date...please advise.