Zachi Fizik of ZF Consulting has been involved with injection molds production since the early 1990s. In the first article in this two-part article series, he'll detail the four milestones that are relevant and necessary for all mold production projects, no matter how tight your budget is or how quickly your deadline looms.
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending
Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.
Continuity Is The Key To Success For Your Medical Device Company
When your company focuses on improving its bottom line, two common methods are to reduce the size of the workforce or to divest from direct manufacturing responsibility. Also, gone are the days when an employee stays with a company until they retire. As a result of these factors, many medical device companies are losing valuable experience. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, discusses what a company can do to address this knowledge drain.
The 3 Compliance Aspects For Passive Predictive Monitoring Device Success
The healthcare and life science industry has been undergoing a digital transformation, and the global COVID-19 public health emergency has accelerated the development of at-home monitoring products. Understanding the regulatory compliance landscape is critical for getting these products on the market and in patients’ hands quickly.
Improving Health Outcomes With Personalized Apps
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.
MED DEVICE ONLINE CONTENT COLLECTIONS
Each drug delivery scenario presents unique challenges. Teams developing the drug must work hand-in-hand with teams developing the delivery device, ultimately agreeing on the proper combination of elements to best serve the intended patient pool. In this eBook, our editors have assembled insights from some of the experts in this field among our editorial contributors.More Content Collections