(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
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
Standards Reconnaissance Subscription Service Coming Soon
Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines? How much time does it take to put this list together and how much
Impact of the Draft report on the EU MDD proposed regulations
This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com) If you are reading this post my guess
Eisner Safety Consultants to Restart Monthly Newsletter Service
It has been over 2 years since we sent out our last newsletter. Our apologies. We have decided to send out a monthly update of our blog posts for each month which are all located at www.EisnerSafety.com/Industry_News/. We have been working