This post will help you understand some of the steps you should start taking immediately to implement your new ISO 13485:2016 QMS. Updated with additional info on 29 February 2016 and 5 April 2016 (Update is italicized) Are you ready
Why Using Proper Standards for Your Regulatory Submission is So Important – Podcast
Jon Speer, founder and VP of QA/RA @ greenlight.guru and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a really interesting & dynamic conversation that we are sharing as a podcast with you on the use of the proper standards
greenlight.guru Partners with Eisner Safety Consultants
We strive at Eisner Safety Consultants (ESC) to provide the best services for our clients and we have found one that is ideal for many of our small to mid size medical device companies we work with. greenlight.guru produces
FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices
On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”. The Guidance was developed to describe the types of information that the FDA expects to be
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.