Although many device companies are seeking cost savings when seeking sourcing products or components manufactured in Asia, quality should not be compromised. Intense due diligence is important.
The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
As medical device costs continue to be a growing area of hospital expenditures, many hospitals control the savings through device reprocessing programs. The shift toward planned obsolescence is especially troubling given the financial challenges many hospitals face.
Does your company understand the magnitude of the compliance effort?
The data that medical devices use is one of the most sensitive types of information.
Here’s what these three CEOs think about why the transition to digital is more important than ever.
The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
Hackers and their ability to access systems remotely and disrupt healthcare organizations are a key concern.
A guide to what to expect during your certification audit and how to prepare.
A review of the status and prospects of key markets in India, Thailand, Indonesia and Vietnam.