When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.
It’s not just about architecture; what are the critical systems engineering roles and responsibilities?
Creating a simple-to-use product is vital to creating a great user experience in any industry, but in the medical industry, simplification can, quite simply, save lives.
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.
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?
