This article answers the question, “how can lean thinking be applied to areas like QARs, QC tests, and document control procedures to remove waste while still adhering to regulations?”
India's Central Drugs Standard Control Organization (CDSCO), the country’s national regulatory authority for both drugs and medical devices, is forming a new division that works exclusively with medical devices. Here’s what we know so far.
Guideline on the Quality Requirements for Drug-Device Combinations (EU) and Principles of Premarket Pathways for Combination Products (U.S.) are the latest attempts to regulate combination products. Here, we examine the two guidances in detail, beginning with the U.S. regulatory guidance.
This is the first article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules.
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.
What is our readers’ greatest shared concern? Demystifying the constantly evolving regulatory landscape each medical device must navigate before it can help patients. Learn more in this free collection of articles highlighting how regulatory confusion can be time-consuming, costly, and damaging to your brand.More Content Collections