The results of usability testing and expert reviews can be inconsistent across evaluators. How can we make these more reliable?
Should you design your perfect product or begin with your minimum viable product?
The most important piece of information that you can garner for Article 80 is the change in time-period duration for record retention.
There are some unique record-retention requirements associated with Ministerial Ordinance 169: So employ a little bit of common sense and script just one well-written SOP for all of your organization’s needs.
MHLW MO 169 – Chapter 4 – Training
There are specific training requirements associated Article 77 to ensure personnel have specialty training; ensure that this training is well documented, including records and a well-written procedure.
This week we explore the collected knowledge of work by three research institutes (National Academy of Sciences, Seoul National University and UC Santa Barbara) to image possibles within our medical device design and development applications.
A key to understand the emotional relationship between a product or service and a user is to find the tacit knowledge and latent needs of the user. But what the user has a personality that does not like to participate?
Part I in a series of articles that will provide insight into TSP, its applicability to the medical device industry, and how it helps achieve the high level of software quality required for devices.
The implementation of human factors engineering throughout the design process will be critical for emerging mobile health applications, not only because FDA is regulating these new mobile medical devices, but because it’s good practice and is an essential tool for decreasing patient safety risks while increasing usability and effectiveness.
Spring Design in Product Development
If required in the product, the spring is probably the least expensive component of the assembly. However, if it does not function as intended or fails, it can become a warranty issue which can be quite expensive as far as repair, loss of sales and product reputation.
