Foreign device companies can expect a big opportunity for expansion in Southeast Asia.
If you’re thinking of handing unsigned documents to FDA during an inspection, think again.
Ernst & Young’s annual Pulse of the Industry report reveals decreasing global revenue and financing in the medtech industry.
The healthcare landscape is changing, and technologies are racing to meet new demands.
Device companies will need to assess their business model in order to compete in an outcomes-based reimbursement environment.
Bringing a product to market in the United States can be complicated, but it can be streamlined with a clear grasp of the process.
Adulteration, misbranding and design validation cause a problem for one company.
To truly understand device use scenario, one must observe with intention.
This tale of medical device theft takes money laundering to a new level.
Some insights on integrating stability testing requirements into a device organization’s plan to make combination products.