Leo Eisner

Medical Device Regulatory & Compliance Consulting Firm - We do: IEC 60601, FDA 510(k)s, EU MDD, Health Canada, Quality Systems, QS Auditing, etc. Come join us!

[Leo Eisner @EisnerSafety]

FDA Cybersecurity Alert: PTC Axeda agent and Axeda Desktop Server https://t.co/RkUo03CRhm

[Leo Eisner @EisnerSafety]

FDA EMC IVD Standards Analysis – https://t.co/0YuSdVxSHC

[Leo Eisner @EisnerSafety]

UK Northern Ireland Marking Guidance Updated – Eisner Safety Consultants https://t.co/4822yqnH41

[Leo Eisner @EisnerSafety]

Regulatory Updates – January 2022 – Eisner Safety Consultants https://t.co/VAdnguzX37

[Leo Eisner @EisnerSafety]

Mark Cuban's drug company launches pharmacy, promising striking savings on generic drugs https://t.co/HkVL4pDxlq

[Leo Eisner @EisnerSafety]

EU MDR & IVDR Harmonized Standards Lists Updated – 9 Added to MDR & 5 to IVDR – Eisner Safety Consultants https://t.co/bClzJOS3aG

[Leo Eisner @EisnerSafety]

Wound care app allows for home assessment https://t.co/A0MNohwsy7

[Leo Eisner @EisnerSafety]

Creating the Artificial Pancreas https://t.co/7TSbCRPjEX

[Leo Eisner @EisnerSafety]

Bionic Hand Gives Amputees Sense of Touch https://t.co/xR7UhJVNgA

[Leo Eisner @EisnerSafety]

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 https://t.co/8O1VbRXODa

[Leo Eisner @EisnerSafety]

EU Commission proposal for progressive roll-out of IVDR EU 2017/746 to be sent to EU Parliament & Council for adoption https://t.co/Vuh72c5Tum

[Leo Eisner @EisnerSafety]

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 https://t.co/Jm1HdiXr1O

[Leo Eisner @EisnerSafety]

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. https://t.co/Z1Q1R6kQLA

[Leo Eisner @EisnerSafety]

Watch - What manufacturers need to know about FDA's ASCA Program with Leo Eisner the "IEC 60601 Guy" and Eric Franca FDA https://t.co/zOvHREYT4e

[Leo Eisner @EisnerSafety]

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 https://t.co/xcRJEWsiSr. https://t.co/xcRJEWsiSr

[Leo Eisner @EisnerSafety]

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 https://t.co/jvvYxjQsP4

[Leo Eisner @EisnerSafety]

3D Printed Solid-State Battery Rivals Lithium-Ion https://t.co/fFrOZgHnZH

[Leo Eisner @EisnerSafety]

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 https://t.co/AoniPJMRFb

[Leo Eisner @EisnerSafety]

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) https://t.co/dQl7rYNKkH

[Leo Eisner @EisnerSafety]

Meet Hearables vs wearables, The Next Revolutionary Medical Devices https://t.co/ss4FYlhXBk