Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success. What would cause business partners to look at quality in such a way?
By addressing four areas of common requirement, medical device companies will be in a stronger position to secure authorization and maintain products on both the US and EU markets.
Effectively conducting a uFMEA not only facilitates correct identification of existing usage risk, it aids in the generation of crucial design updates for risk reduction or elimination.
On Sept. 6, 2018, FDA announced the launch of a new pilot 510(k) program. This initiative, the Quality in 510(k) “Quik” Review Program Pilot, proposes an alternate pathway to regulatory submission and approval for medical devices. Quik is in its early stages and is therefore limited in scope, but it nonetheless offers another approach to premarket notification. This article examines what makes Quik different from traditional 510(k) submissions, plus its benefits and challenges for medical device manufacturers.
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.