Leo Eisner

FDA Cybersecurity Alert: PTC Axeda agent and Axeda Desktop Server bit.ly/3hSQMnB

FDA EMC IVD Standards Analysis – bit.ly/FDAEMCIVDStdsA…

UK Northern Ireland Marking Guidance Updated – Eisner Safety Consultants bit.ly/3ASuNWt

Regulatory Updates – January 2022 – Eisner Safety Consultants bit.ly/3obiDTD

Mark Cuban's drug company launches pharmacy, promising striking savings on generic drugs bit.ly/33HaJu0

EU MDR & IVDR Harmonized Standards Lists Updated – 9 Added to MDR & 5 to IVDR – Eisner Safety Consultants bit.ly/3FaDGv2

Wound care app allows for home assessment bit.ly/311xbgg

Creating the Artificial Pancreas bit.ly/3rrpDhJ

Bionic Hand Gives Amputees Sense of Touch bit.ly/3DHRyx0

CDRH Digital Transformation Initiative To Strengthen Premarket Review covers 4 initiatives: Customer Collaboration Portal, Submission Memo & Review Template (SMART), electronic Submission Template & Resource (eSTAR), & Decision Management Portal bit.ly/3AIzLU3

EU Commission proposal for progressive roll-out of IVDR EU 2017/746 to be sent to EU Parliament & Council for adoption bit.ly/2YRFpWD

FAQs on ISO 15223-1 – We did a really popular webinar ATTENTION ⚠️ ISO 15223-1 4th Edition is Almost Here: How to Update Your Medical Device Labeling to Comply with the New Requirements. Lots of questions came from the webinar. We decided to write an FAQ bit.ly/3B0SQC9

Consultation on the future regulation of medical devices in the United Kingdom "The ... MHRA is working to develop a world-leading future regime for medical devices...feedback...to help shape our future approach to regulating medical devices in the UK. bit.ly/3khYGJ6

Watch - What manufacturers need to know about FDA's ASCA Program with Leo Eisner the "IEC 60601 Guy" and Eric Franca FDA bit.ly/3kUr8jE

The 23rd MDR Notified Body has been added to the list of Notified Bodies as of 2 Sept 2021. Please check the NANDO db for details of each NB to make sure you pick the right NB for your company bit.ly/2TH4JZ7. bit.ly/2TH4JZ7

What manufacturers need to know about FDA’s ASCA Program – Free Mini BioPro series Join FDA & Leo Eisner of Eisner Safety Consultants Tue 31 Aug 2021 Noon - 1PM Pacific bit.ly/Whatmfrsneedkn…

3D Printed Solid-State Battery Rivals Lithium-Ion bit.ly/3mgdhGt

Free online event - What manufacturers need to know about FDA's ASCA Program - Mini BioPro series - Oregon Bioscience Association - Presented by Leo Eisner, Eisner Safety Consultants & Eric Franca, FDA/CDRH bit.ly/2WShPIn

Medical devices: UK approved bodies - Be aware to check the specific scopes of each UK approved body (only 3 approved bodies, only BSI approved for all 3 Med Dvc Scopes, whereas SGS for 2 & UL UK for IVD scope only) bit.ly/3lkwZQP

Meet Hearables vs wearables, The Next Revolutionary Medical Devices bit.ly/2VqcmYu