Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.
CAPA provides visibility into critical product quality characteristics, failures/ non-conformances, and resolutions to these issues for smarter decisions across the global, extended enterprise. With the right solution, design, manufacturing and quality improvement teams can share the same views of the information they need to directly impact Six Sigma and Lean initiatives.
Whether you’re an engineer, designer, or technical tinkerer, here’s a basic road map to a few of the most important aspects of modern 3D printing.
Despite a clear need to get better development lifecycle management solutions in place, companies are restricted by tight budgets, validation overhead, and bureaucracy. In this Q&A, Matt Harp and Angie Pepiot at Seapine Software share their insights.
Customers have basic goals and expectation of silicone adhesives that it can hold the device or dressing in place while the device performs the intended function, until the time the clinical objective in achieved – Kris Godbey, 3M Medical Specialties.
Additive manufacturing capabilities align well with the needs of the medical device segment, enhancing product customization and enabling efficient, cost-effective production and delivery, describes Deloitte’s Glenn Snyder.
Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.
To ensure that you are choosing the contracting partner that will help carry both parties into the earning margins desired – it is essential that a set of criteria is used to establish the perimeters for how to choose that partner, including the specifics of what things to look for.
Defiant minds can conceptualize embodiment that customers actually want. But determining methods to best define what the customer wants with novel technologies can be challenging as many of the methods published just don’t fit early stage work. How can we then manage the process of quality function deployment?
As wearables for smart monitoring require efficient components, it is estimated that 67 percent more 3D printers will be sold this year, than in the previous year, and the medical field is an area of application with great potential.
