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.
Device establishments must maintain records of acceptable suppliers.
There is still much to learn about the benefits and potential of robotic surgery.
The new MDR introduces several changes that manufacturers must consider right away.
If an activity is not documented, it did not happen.
Low-cost production centers make these markets an attractive option for manufacturing.
Although not always subject to receiving inspection, defining control of non-inventory items, such as manufacturing materials, is critical.
When responding to a 483 observation, clarity is a must: Both in communication and documentation.
This offending company has “significant” violations regarding reporting corrections and removals to FDA.