Advances in the technology that enables production of 3D-printed medical devices continues to outpace development of the regulations, standards, and best practices intended to guide design and delivery of such devices. Learn how to insulate yourself from the resultant legal, regulatory, and business risks.
The Medical Device Single Audit Program (MDSAP) is recognized by officially approved Auditing Organizations (ISO Registrars) to conduct a single regulatory audit, of a medical device manufacturer, that satisfies relevant requirements of the regulatory authorities participating in the program.
Latin America is developing into a sizable, predictable part of the global medical device market, allowing foreign manufacturers to have sustainable commercial operations.
This article explores the adoption of intracranial stenting across three major markets (U.S., Germany, South Korea) and projects the overall market opportunity according to currently approved indications.
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.