Eisner Safety Consultants

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 (non-medical robots) and IEC/TC 62 and its subcommittees to establish a new Joint Working Group on [...]

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 Las Colinas Blvd., Irving, TX.  The meeting will not be videotaped or webcast and will [...]

  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, and the impact of change on industry Usability and Human Factors verification, validation, and regulatory [...]

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 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.