ABSTRACT
This chapter guides medtech start-ups on key considerations, especially with regard to the bulk of regulatory and quality activities and expected outcomes in the product design and development phases of a medical device. The intended use of the product has a significant influence in determining the product classification, which in turn defines the regulatory route and associated requirements needed before the product may be marketed. Medtech start-ups often misunderstand or underestimate the quality management system documentation, product testing and manufacturing information sufficient to prepare for submission dossier to the authority or the conformity assessment body. Quality management system (QMS) is defined as the organisational structure, responsibilities, procedures, processes, and resources needed to implement quality management. Medtech start-up needs to properly assess available clinical data sources, with consideration of the state of the art standard-of-care or best practice, in order to provide clinical evidence to substantiate the product can be used safely and effectively based on the product’s intended use.
