Axendia Report: The Costly Impact of Ineffective Requirements Management
In this medical device research study from Axendia, a leading Life-Sciences Analyst firm, see how ineffective requirements management can negatively impact budgets, traceability, and V&V activities.
Read
Why Move Away from IBM® DOORS® Legacy, and Why Now?: Part 2
This is Part 2 of a series examining the role legacy requirements management solutions, such as IBM® DOORS®, play in introducing project risk to the product development process. To read Part 1, ...
Read
3 Ways Requirements and Risk Management Continue After Market Launch
Congratulations! Your organization has gained regulatory approval and launched its medical device product. The ‘History’ in Design History File may elicit impressions that all those design and...
Read
Why Startup Medical Device Companies Should Prioritize Requirements and Risk Management Before QMS
As a medical device product development consultant, I often see start-up companies having trouble deciding what to prioritize – design controls and risk management or the quality management system...
Read
With Jama Connect®, TELEDYNE e2v Improves Communication, Review Cycles, and Efficiencies, Reducing Risk in the Development Process
In this post, we look at how Teledyne e2v leverages Jama Connect for improved communication and better risk management. Teledyne e2v is a global leader in specialized components and subsystems...
Read
Five Key Design Control Practices that Improve Compliance and Help Develop Better Products
Design Controls have been an FDA Quality System Regulation since 1997. Having worked on developing products in the regulated medical device industry for over 35 years, I have compiled a list of...
Read
Regulatory Shift for Machine Learning in Software as a Medical Device (SaMD)
Machine Learning in Software as a Medical Device Machine learning (ML), a subset of artificial intelligence, has become integral across software in all industries, and the medical and life science...
Read
8 Do’s and Don’ts for Writing Requirements
Every word matters when authoring requirements. In this post, we discuss the top dos – and don'ts – for successfully writing requirements.
Read
Keeping Autonomous Vehicles on Track
Experts discuss actions engineers can take to stay nimble, innovative, and reduce safety-critical mistakes throughout the development process.
Read