From Information Week — 29-JAN-2011 there is a great article showing twelve advances in Medical Robots A proposal has been circulated, on 21-JAN-2011, for a vote to form a Joint Working Group between ISO/TC 184/SC 2, Robots and robotic devices
FDA Town Hall Mtg 3/10 with Dir. of CDRH, etc. – Irving, TX
There will be an FDA Town Hall meeting on March 10, 2011 with the Director of CDRH and with other top management of the CDRH. The meeting will be held at the Irving Convention Center at Las Colinas, 500 West
Leo Eisner Presenting at RAPS/ASQ on IEC60601-1 3rd ed.
Biomedical Division Northern California Discussion Group andSan Francisco Bay Area Chapter Topic: “Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas: IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration,
FDA Updates 515 Prog. Initiative Webpage (reclassified preAmend Class III 510(k)s)
The FDA updated the 515 program initiative webpage also known as reclassification of preAmendment Class III 510(k)s. Currently there are 26 Class III products going thru the 515 program initiative and you can view the status of the 515 project.
FDA Warning Risk of Injury from Lasers Pointers, Etc.
FDA issued a Safety Notification on Dec 16, 2010 that any lasers rated 5 milliwatts (mW) or more can cause temporary or permanent damage to skin or eyes. The full FDA safety notification can be accessed by clicking here.