Verification & validation in medi spice

non-peer-reviewedEffective verification and validation are central to medical device software de-velopment and are essential for regulatory approval. Although guidance is available in mul-tiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domai