Medical Device Development Life Cycle

It may be a completely new device that will save thousands of lives or improve the quality of.

Medical device development life cycle.

The medical device marketplace can be a tough nut to crack. Preclinical clinical regulatory and post market stages. In contrast implanted medical devices may undergo dynamic changes in function and safety over years or even decades. It only gets more complicated when you want to enter various marketplaces.

After conceptualizing a new medical device the next step in its product development is the design this is the most important stage in the development of a medical device since a flawed design may lead to it being ineffective or unsafe that is not approved or cleared by the regulatory agency. In response new approaches to device development are emerging to streamline the process with the goal to make it easier and more effective overall. One novel model is to integrate the four key components of development that span the medical product s life cycle. 1 at the design stage a design control process needs to be initiated and implemented as part of.

Iec 62304 is the international standard that defines software development life cycle requirements for medical device software iec 62304 was developed from the perspective that product testing alone is insufficient to ensure patient safety. Aside from the conceptualization and manufacturing there s a ton of paperwork that needs to be done to see any success. Medical device regulators in the past have focused quality regulations on the device design and development process but more recently updates to medical device standards such as iso 13485 2016 have seen the inclusion of additional post market requirements reflecting an added emphasis on full life cycle management of medical devices. It may be due to a healthcare practitioner wanting life to be easier for them during a medical procedure which involves the innovation of a new device.

By adnan ashfaq march 5 2018. New medical device development life cycle. These factors have a major impact on the medical device development cycle which can be broken down into five major stages. The outcomes of each stage have a direct effect on subsequent ones.