What Does Big Data Mean For Medical Devices?
The term “Big Data” is a few years old, but its implications for medical devices is at an inflection point.
Where Have All the Systems Engineers Gone? Part Three
This installment covers what’s missing and what pain does it cause. Without systems engineers, what is the impact to project teams and organizations?
Four Ways Risk Analysis and Verification Testing Can Help Prevent Recalls
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.
Where Have All the Systems Engineers Gone? Part Two
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.
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.
