Verification & Validation in Medi SPICE
نویسندگان
چکیده
Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple 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 domain.
منابع مشابه
Development of the Medi SPICE PRM
As the importance and complexity of medical device software continues to increase there is growing demand for effective process assessment and improvement in this domain. To address this need the Medi SPICE process assessment and improvement model is being developed. Regulatory compliance is both an important and challenging aspect of medical device software development. Particularly as new reg...
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