Clear and accurate product requirements at all stages of the project are key. It is not enough to manage them. Designers need to rethink how they are written.
TORONTO (PRWEB) October 21, 2020
Why focus on product requirements?
New technology development in the medical device arena has led to increasingly complex new products. This trend will likely increase due to the increasing market of IoT, SAaMD (SW as a medical device), AI, Health Apps, etc. With increasing complexity comes the advent of errors and device failures. This industry trend is evidenced by an increase in product recalls and security issues. Projections indicate that both the frequency and severity of these problems will continue to rise.
To keep pace and maintain oversight, this has also led to the updates and increases in quality regulations and standards in the EU, USA and throughout the world. At the heart of these are proper design controls which dictate methods and traceability of how the device was developed from user requirements to final verification and validation. Clear and accurate product requirements at all stages of the project are key. It is not enough to manage them. Designers need to rethink how they are written.
Unfortunately, poorly defined requirements are a common problem with complex devices and software. Indeed, software is the number one reason for medical device product recalls and many of these can be traced to issues with the requirements. Ensuring requirements are concise, testable, and clearly understood is both more difficult, and more important than ever. Fortunately, there are established best practices and attributes of properly written requirements.
Join Verna Rodriguez, Founder and Principal, Manty Medtech, Adjunct Lecturer, Bioengineering Department, Santa Clara University and James Carr, Account Executive, QRA Corp in a live webinar on Thursday, November 5, 2020 at 12pm EST (5pm GMT/UK).
For more information or to register for this event, visit The Complexity Threat: Why Medical Device Teams Need a New Approach to Product Requirements.
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