Software traceability is central to medical device software development and essential for regulatory approval. In order to comply with the regulatory requirements of the medical device industry it is essential to have clear linkages and traceability from requirements -including risks -through the different stages of the software development and maintenance lifecycles. The regulatory bodies request that medical device software development organizations clearly demonstrate how they follow a software development lifecycle without mandating a particular lifecycle. However, due to the traceability requirements of the industry most medical device companies adopt the V-model. Within this chapter we will discuss the importance of traceability to medical device software development, the current state of practice within the industry in relation to traceability and how we feel that traceability could be improved within the industry. The chapter also describes the development and implementation of a medical device traceability software process assessment method (Med-Trace) in two medical device software development organizations. We include these two case studies as one involved a medical device SME based in Ireland and the other a medical device SME based in the UK as we want to illustrate that Med-Trace can be applied within different countries.

The benefits of effective verification and validation activities in the medical device domain include increased usability and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though there is guidance on verification and validation in multiple standards in the medical device domain, these are difficult for the manufacturer to implement, as there is no consolidated information on how they can be successfully achieved. The paper highlights three major areas for improvement in the medical device software development domain. This research is based on an analysis of available literature in the field of verification and validation in generic software development, safety-critical and medical device software domains. Additionally, we also performed a review of the standards and process improvement models available in these domains.

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In the past decades, a great deal of attention has been focused on mechanical, thermal or chemical pretreatments of lignocellulosic and algal biomass for the production of biofuel. This chapter is focused on the potential of ultrasound (US) technology in pretreating the biomass to enhance the conversion of cellulose to fermentable sugars and also the disintegration and component extraction of microalgae for the generation of bioethanol or biogas. In addition, US can supplement existing biomass pretreatment methods to greatly enhance their performance and their efficacy. Low frequency ultrasound (LFU, 20-100 kHz) is commonly used in biomass processing, particularly in processes that require intense physical effects such as cell disruption and polymer degradation. High frequency ultrasound (HFU, 400 kHz-2 MHz) recently attracted considerable interest as potential alternative technique for pretreating both the lignocellulosic and algal biomass for sustainable biofuel production. HFU is gaining increasing importance because of its environmentally sound and energy-saving production method since it demands lower energy input for the conversion of biomass. It not only saves time and energy but also lowers the chemical/enzyme dosage and hence novel and considered to be a new sustainable and environmentally-friendly green technique. Although many studies have shown the promise of ultrasound in the cell breakdown for enhanced enzymatic hydrolysis, there is limited information in the application of HFU on biomass pretreatment processes. This chapter provides an overview on the fundamentals of US, the critical parameters that control the conversion of biomass, challenges involved with the application of US in the biomass conversion and its future perspectives.

Abstract. 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.