The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022.
JABIL Cayey is the first manufacturer in Puerto Rico to receive plastics injection molding accreditation through the industry-managed supply chain oversight program.
Data analytics can provide a more streamlined view of your customers and simplify the complex challenges faced by medical device commercial operations teams.
Standalone best-of-breed Enterprise Asset Management (EAM) systems have historically been leveraged to help solve the transactional needs of clinical engineering, IT and facilities. Yet few organizations are currently capitalizing on the wealth of data generated from these systems. In this article, we’ll examine some of these opportunities and offers suggestions as the industry begins developing our “next generation” of EAM systems.
On the journey to full-scale production for medical devices incorporating optics, a series of steps early in the process can make all the difference for successfully launching new products and introducing next-generation upgrades. This article discusses four considerations for a successful product launch.
The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
Although the future is exciting, it also poses real challenges. More collaborative initiatives need to take place between drug manufacturers and developers of manufacturing equipment and consumables.
Increasing demand for custom surgical implants and growing investment in R&D will help the sector experience significant growth over the next five years.
Medical device companies have upped their game in product security and regulatory compliance, but they might not be ready for a catastrophic event.
A Q&A on how device companies can respond to supply chain risks and regulations.
