Jan 1
Design Control, the method to the madness
Bringing a product to market is a challenge, add in the regulatory complications of a medical device and the task can appear overwhelming. But, is it?
Posts by Robert Keur
Aug 3
62366-1:2015 vs Applying Human Factors and Usability Engineering
The application of usability engineering to the design of medical devices is defined by IEC-62366-1. The FDA recognizes this standard but has also published a guidance document describing the process as they see it. Fortunately there are no fundamental conflicts between the two and the guidance is, for me, an easier read.
Aug 5
Data de-identification for personal health information security
Not long ago your medical records consisted of a paper file stored in your family doctor’s office. There was little risk of the contents being stolen, altered or made public. It was rare for patients to see their own records. As the concept of the family doctor has changed to the use of walk-in clinics, […]
Jul 2
Do’s and Don’ts of Medical Device Labeling
As my colleague, Virginia Anastassova, noted in her recent blog, Unique Device Identifiers (UDIs) have been one of the hot topics in the Medical Device world in the last few years. It seems like a good time for a quick refresher on medical device labeling in general. I’ve also included my list of Do’s and […]
Mar 18
StarFish Analysis: Health Canada online publication of Regulatory Decision Summaries (RDS)
Health Canada has announced, as part of the Regulatory Transparency and Openness initiative, online publication of Regulatory Decision Summaries (RDS) and a list of decisions under review. This means more information about medical devices will be available to consumers, and more importantly, health care providers.
Jan 22
How good is good enough? The importance of medical device performance specifications
The phrase “good enough” may have a negative connotation, but it is a critical concept in the development of a medical device. As applied to the device performance levels, knowing what is required to achieve the device’s effectiveness goals is, surprisingly, an often overlooked aspect of the design process. Too often these requirements are assumed, […]
Apr 10
How to write a Medical Device Quality Manual (3 simple rules)
My first experience with a quality manual was not a good one. The manual for an ISO 9000 certified company consisted of the standard with the words “the company will” inserted before each clause. A slight exaggeration, but you get the point. After reading the manual one had very little idea of how the company intended […]
Aug 9
Quality, what is it?
Quality managers don’t have a magic wand that can turn a bad product into a good product. We probably shouldn’t even be deciding what a good product is other than to verify safety and effectiveness. The English language isn’t always precise and one of the best examples of this is the word quality. Ask someone […]
Jun 18
Medical Device Design Control, the Method to the Madness
Bringing a product to market is a challenge, add in the regulatory complications of a medical device and the task can appear overwhelming. But, is it? All of the regulatory processes are aimed at proving a device is safe and effective. One would hope that regardless of the regulatory requirements those goals would be a […]
Apr 4
Risk Management as a Design Tool in Medical Device Development
How do we define the quality of a medical device? What attributes cause us to come to the conclusion that a device is a “quality product”? The safety of the device, if mentioned at all, usually follows fit and finish, reliability and performance in the list of attributes we think of in connection with quality. […]