Cost savings and the ability to meet high-volume demands are enticing benefits.
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.
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.
Low-cost production centers make these markets an attractive option for manufacturing.
The agency wants to modernize its regulatory processes and make them more efficient.
After the abrupt announcement, the search is on for a permanent successor.
European scientists have developed a handheld scanner that works similar to a supermarket scanner for early detection of cardiovascular disease.
The Inspiris Resilia valve is intended for aortic valve replacement.
The agency has cleared expanded use of the DigniCap for solid tumor cancers beyond breast cancer.