The Class I recall affects the Roadrunner Uniglide Hydrophilic Wire Guide, which is used in peripheral vascular procedures.
The United States paves the way for seamless compliance.
How can medtech manufacturers navigate the roadblocks?
Define, document and implement!
The expanding international market poses a variety of challenges for medtech companies entering new global territories.
Cleanroom monitoring requirements—you can’t ignore them.
The agency clarifies the UDI rule for labelers and accredited issuing agencies.
With the consent decree, the risk of financial death is very real.
Are you UDI-ready? Get the facts to achieve compliance fast.
Agency sanctions include a monetary penalty and revocation of the lab’s CLIA certificate.