Are you in the process of designing a medical electrical device or need some help in meeting IEC 60601-1 and related standards? Do you need help with a medical device regulatory submission or your quality system? Also, we have a team of medical device experts
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
ISO 13485:2016 is Now Available – Start Planning Your Transition
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