Product life-cycle management for medical device design and development: A guideline for implementation

FLORENCIA GARRO; GIGLI JUAN PABLO

córdoba

Congreso; SABI 2017 : XXI Congreso Argentino de Bioingenieria. X Jornada de Ingeniería Clínica; 2017

SABI - Universidad nacional de córdoba

Abstract? The design and development of medical devices implies numerous challenges in the present. There is a growing demand of innovation in the field, which requests medical devices with minimum invasive techniques and larger benefits for physicians and patients, along with a more exigent and variable regulatory requirements to guaranty the product safety and efficacy. This leads to the need to position successfully a product on the market maximizing the resources efficiency, in order to develop a safe medical devices in a short period of time, satisfying the global market and regulatory requirements.In order to deal with the complexity of the involved process of medical devices design and development, the industry is developing new management strategies, aligning its processes with the standards and strategies of good practices throughout the life of the product, managing resources efficiently and satisfying regulatory and quality guidelines that a medical product must meet.This paper proposes the design and development management supported by the product life-cycle management as a methodology. The problems associated with the design and development of medical devices are analyzed, and then an implementation model within the area of design and development of a medical device company is proposed.