Why design verification& validation matters in medical device design and development Design verification can be an important stage for all medical device companies to carry out efficiently. This involves not restricting your testing during R&D stage only but taking it up at each stage progressing. The Design Verification The objective of design verification is to prove your design outputs are matching design inputs. This means the user required certain type of product so user gives certain input for product requirement it might have been described in his terms and not in very specific term of medical device language .Now the design engineer has to understand this in terms of its feasibility, making it, strengths needed and other properties needed. This will be incorporated as design input and which will be quite elaborate then what user might have described briefly. Once product is designed as per R&D or design engineer then verification involves that all user needs which are now translated into input by design engineer are available as output. Another good term to make sure efficient design verification is to consider how you will verify design inputs before moving forward to the design process. In other words, you should think about and plan for design verification at the initial possible stage. This is important steps as some of the input parameters may be difficult to test but must be incorporated correctly so at initial stage only plan out as to how you will verify that input parameter which may involve verifying that with another conjugate parameter. The Design Validation This term is totally different from verification. Verification means whether you designed the product correctly considering all inputs which are verified as output in designed product. This means input and output matching verification. Validation is intended to prove that you designed the right product which user wanted as per limited input given. Now this can be proven only on live product. So, design validation must refer all the way back to user needs. Design validation usually occurs when you are in the final stage of the design process and it usually involves using a small batch production run of the product. Importantly, the product must be fully produced including all packaging, labelling, usage instructions, and anything else that will be with the product when it is launched on the market. Everything must be validated. This means that now you are ready to meet user needs and you will provide user the actual product where in all input are suitably considered. This means that if order is given for orthopaedic implant of specific size the design has considered the material, strength, movement, material biocompatibility. The doctor in this case is user will give just size through scan etc. and no other things.
Validation shall cover all aspects and all input considered in design including that of users. The Importance of Design Verification and Design Validation Both design verification and design validation are essential processes to go through and document to ensure your new medical device product gets regulatory approval. The processes also improve the design of your product to give it the best possible chance of success. This may also happen that company A and B makes same product, but Company A product is superior because it is designed as better way with much better inputs and all inputs are verified as outputs and finally validated through actual small or normal batch manufacturing.