Cost savings and the ability to meet high-volume demands are enticing benefits.
The agency has alerted healthcare providers of unanticipated deaths related to the systems intended to treat obesity.
According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.
Device establishments must maintain records of acceptable suppliers.
A guide to the steps companies can take to evaluate their device developer’s HFE process.
The Avalus pericardial surgical valve is intended for patients with aortic valve disease.
Know how IQ, OQ and PQ—the three essential elements of a Quality Assurance System—govern the medtech sector.
The new MDR introduces several changes that manufacturers must consider right away.
Earlier this year, the CFDA introduced significant changes to the drug and device approval process.
If an activity is not documented, it did not happen.