TTP's Software team has released a new guide exploring how medical device developers can manage the complexities of regulated medical device software development, balancing the need for development speed with safety, compliance and long-term product performance.
The e-book, Medical device software lifecycle management, examines the engineering decisions that shape regulated medical software development, from software architecture and risk management to verification, traceability and cybersecurity. It explores how integrating these activities throughout the development lifecycle can help teams avoid costly rework, maintain control as software evolves and support efficient development.
Brendan Ronayne, Head of TTP’s Software team, explores how an IEC 62304-aligned development lifecycle, supported by an ISO 13485 quality management framework, can help developers establish appropriate engineering rigour from the outset. He also considers how early architectural decisions, well-defined interfaces and connected verification evidence can make complex software systems easier to develop, maintain and adapt.
The publication reflects the growing importance of connected and evolvable software in medical device performance, medical device differentiation and commercial value, alongside the need to manage regulatory expectations and ongoing software changes throughout a device's operational life.
The free e-book, Medical device software lifecycle management, will be relevant to engineering and R&D leaders developing regulated medical devices, from start-ups bringing new technologies to market to established organisations managing increasingly complex software systems. It offers practical engineering perspectives on reducing development risk, maintaining regulatory confidence and building software that can evolve over time.
The e-book is now available to read and download for free here.
