Jon Speer, founder and VP of QA/RA @ greenlight.guru and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a dynamic & interesting conversation that we are sharing as a podcast with you on tips for success when it comes to
Home Use Medical & Wellness Devices Article by Leo Eisner
Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an
ESC New Annual Standard Reports Available by Early April ’16
(Note this service is not offered anymore please contact us with your questions.) Do you make Medical Electrical Equipment & Systems (MEE&S) or Home Use MEE&S? Are you up to date on all the applicable Current & Draft Medical Electrical
CAN/CSA C22.2 No. 60601-1:14 Added to Health Canada’s List of Recognized Standards
This post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015. Health Canada updated their list of Recognized Standards for Medical Devices on August 31, 2015. The changes included additions, updates and removals to the listing.
Standards Reconnaissance Service Coming Mid Oct ‘15 to Eisner Safety Consultants
Do you want to ensure standards compliance to meet quality & regulatory requirements? Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed