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 510(k) changes announcement Jan 19 2011 from MassDevice
MassDevice online article 1/19/2011 – The FDA 510(k) changes are to be announced today, Jan 19 2011. http://ht.ly/3Gz2O
Leo Eisner Presenting @ DesignMed on IEC60601-1-11 Home Healthcare
Topic: “Make sense of the IEC 60601-1-11 standard” The Medical Electrical Device Collateral Standard in the Home Healthcare Environment Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Joseph Murnane of Underwriters Laboratories When: Feb 10, 2011 (Thursday)
Med Dvcs E-Lableing: Health Canada TPD’s Interpretation
On November 9, 2010 Health Canada’s Therapeutic Product Directorate (TPD) issued an interpretation of the Medical Devices Regulations (Regulations) with respect to electronic labeling (e-labeling) of certain medical devices sold or imported into Canada. This interpretation only covers products for