January 27-28, 2012: We will be attending and exhibiting at the CMIA Annual Symposium in Brea, CA and will be presenting two separate educational programs; 1) Meeting & Exceeding JCAHO Requirements on Endoscopes: Going the Extra Mile to Achieve True Cost Savings in Endoscope Service and Repair and 2) Evolution of Defibrillator & Defibrillator Testing Technologies - With Special Emphasis on Multi-Phasic Waveform Morphologies, AED's, and Variable Load Testing According to Established Standards.

October 20-23, 2011: We will be attending the MD Expo in Orlando, FL and will be presenting an educational program on Meeting & Exceeding JCAHO Requirements on Endoscopes: Going the Extra Mile to Achieve True Cost Savings in Endoscope Service and Repair. Join us in Orlando in October for the MD Expo and sign up for this educational presentation.

September 15, 2011: We will be attending and exhibiting at the CMIA 4-Chapter Northern California Event (formerly the 3-chapter event but now including the CMIA Central Coastal Chapter + Bay Area Chapter + NorCal Chapter + Capitol Chapter).

September 14, 2011: We will be hosting the CMIA San Diego Chapter meeting on this evening and will be presenting an educational program on Meeting & Exceeding JCAHO Requirements on Endoscopes: Going the Extra Mile to Achieve True Cost Savings in Endoscope Service and Repair.

August 10, 2011: We will be hosting the CMIA Bay Area  Chapter meeting on this evening and will be presenting an educational program on Meeting & Exceeding JCAHO Requirements on Endoscopes: Going the Extra Mile to Achieve True Cost Savings in Endoscope Service and Repair.

July 20, 2011: We will be attending and exhibiting at the CMIA 4-Chapter Southern California event to be held at the Doubletree Hotel in Santa Ana, CA.

July 1, 2011: Datrend Systems (www.datrend.com or www.datrend-usa.com) announces the planned first shipments of their new IncuTest Infant Incubator and Radiant Warmer Testing System for August 2011, and the new FMS-3 Fetal/Maternal Simulator for 4th Quarter 2011 (by the end of the 2011 calendar year)

June 17, 2011: We will be hosting the CMIA Capitol Chapter meeting on this evening and will be presenting an educational program on Meeting & Exceeding JCAHO Requirements on Endoscopes: Going the Extra Mile to Achieve True Cost Savings in Endoscope Service and Repair.

May 19, 2011: We will be hosting the CMIA NorCal  Chapter meeting on this evening and will be presenting an educational program on Meeting & Exceeding JCAHO Requirements on Endoscopes: Going the Extra Mile to Achieve True Cost Savings in Endoscope Service and Repair.

November 12, 2010:  The FDA is starting to place increased scrutiny on the calibration accuracy and quality of calibrations of not only biomedical test and measurement equipment, but on general test equipment as well according to this article by Shawn M. Schmitt of "The Silver Sheet" (originally published in June 2010).  Are you prepared for this scrutiny?  Make sure you are working with more than a "lick-'em and stick 'em" calibration company! Be sure to ask for a copy of their calibration standards and verify that you are getting a real calibration according to traceable standards and per an acceptable procedure, and NOT just a calibration verification service without any real standards or traceability!   Link to article.

October 28, 2010:  NEWS FLASH -- Last Week, Howard Sklamberg, Director of the Office of Enforcement at FDA said the agency has stopped sending repeat offenders warning letters, instead they are going straight to enforcement! Sklamberg said the agency is targeting seizure of products or sales injunctions as likely punishments.

October 25, 2010:  AAMI launches its new "Ask George" forum.  Link

October 24, 2010:  Datrend Systems (Vancouver, BC, Canada) and EQ2 (Burlington, VT) announce the availability of a communications interface between the Datrend ES601 Plus Automated Electrical Safety and Performance Analyzer and the EQ2 HEMS Software.  Click here to view the Press Release.

October 14, 2010:  AAMI releases "Top 13 Priorities for Infusion Pump Safety".  Link

October 14, 2010:  More tough words from the FDA regarding companies that refuse to "play by the rules".  Link

October 8, 2010:  MRE Dynatech NV LLC will no longer be able to supply radiology test equipment as manufactured by Diagnostic Imaging Specialists Corporation (DISC).  We were notified on this date that DISC is changing their marketing and distribution strategy for this part of the U.S., and we are as of this date, no longer affiliated with DISC.  Please refer all of your future product inquiries directly to them.  The DISC website can be found at http://disccorp.mb.ca/.  We deeply apologize for any inconvenience that this change may cause for prospective customers.

October 8, 2010:  Diverse interests tackle infusion device safety issue.  Click here for additional details on the AAMI website.

October 4, 2010:  Due to a change in marketing strategy, for at least the present time, MRE Dynatech NV LLC will no longer be able to supply the UW-6 Diagnostic Ultrasound Wattmeter by Bowles Corp. of North Ferrisburgh, Vermont.  For cost quotations or more information about the UW-6 product, please contact Bowles Corp. directly. They would be delighted to work with you directly.   Bowles Corp. website.

October 1, 2010:  Fluke Biomedical announces that FDA 510(k) clearances are required for patient simulators and NIBP analyzers. The text of this new advertisement says.........

Regulations matter.
Did you know the United States Food and Drug Administration has determined NIBP and ECG patient simulators to be Class II medical devices? Class II medical devices sold in the United States legally require FDA 510(k) clearance.

See this new announcement piece by clicking here.

September 7, 2010:  TMC Leader Appointed to JC Patient Safety Group... see more details on the AAMI website by clicking here.

August 2010:  The Joint Commission has imposed a requirement on hospitals regarding the maintenance and care of flexible and rigid endoscopes.  It follows that consideration must be given to some type of testing on these devices as well.  George Mills reported at the 2010 AAMI Annual Conference in Tampa, FL that the JCAHO now requires clinical engineering departments to include endoscopes in their equipment inventory.  To see more information on the AAMI website, click here.

August 2010: Decision could affect PM Strategies... click here to see more on the AAMI website.

August 10, 2010: The FDA has officially recognized the AAMI Version of international standard on medical electrical equipment. Click here to see additional details on the AAMI website.

August 4, 2010:  Manufacturers may face tighter FDA regulations.  Click here to see more details on the AAMI website.

January 26, 2010:  FDA to hold 510(k) meeting.  Click here to see additional details on the AAMI website.

January 10, 1997:  FDA 510(k) Memorandum on deciding when to file or update a 510(k) submission.  Click here for the FDA memorandum PDF.