Developing a medical device is complicated. Beyond the combination of hardware, software, advanced technologies such as imaging and other components to make the product, there is the critical importance of patient outcomes as well as patient and user safety when using the device. In the first of our multi-part series, Resolution will explore the challenges of compliance and outsourced product development as it relates to IEC 60601. At the end of this series, we will be issuing a whitepaper on our website taking an in-depth look at this critical area. Ensure you are up to date by regularly visiting our blog.
Until recently, most medical devices were used by trained healthcare professionals in a hospital or first responders, etc. With the expansion of tools available and rising healthcare costs, many modern technologies are now available for use by lay people in the home. As such, the requirements have changed for the use of these instruments, and the standards have evolved to address the changing environment. Some standards have been revised and new standards have been introduced.
IEC 60601-1: 2012 outlines the general requirements for basic safety and essential performance for all Medical Electrical Equipment. Edition 3.1 of the general standard has more fully defined the Risk Management Process, to comply with ISO 14971:2007. The third edition has also introduced Usability, replacing what had been previously defined as “user or human errors”, and the concept of Home Use by a lay-person. There are many ways in which to apply these requirements to your outsourced product development program whether for new product development or for updating an older design to achieve compliance.
Clearly defining Essential Performance and appropriately applying design risk management are at the core of these updates to the general standard and can mean the difference between compliance and costly program delays. Documentation for all aspects of your device is a crucial piece of a robust compliance package.
The regulatory landscape can be difficult to navigate for both small and large companies. Appropriate guidance, identification and application of standards which include IEC 60601 is a key factor in determining development time, an efficient regulatory approval cycle and ultimately time to market.
Many outsourced product development companies underestimate the time and resources required to develop and validate a product in this strict environment. Development of a device that complies with the appropriate regulatory standards can be a complicated and confusing process; however, Resolution Development Services’ program management team is active in the regulatory community. The team stays updated on current regulations and any expected updates. Our experience performing outsourced medical device product development that adheres to the strict regulatory requirements makes Resolution the perfect choice for any highly regulated, complex project. Our quality management system has been selected for its expediency and compliance for Class III medical device development by Fortune 500 companies, and we have successfully passed quality audits.
In the next part of our series, we will explore IEC 62304 and legacy code.
To learn more about Resolution Development Services, visit us at www.resolutiondev.com