Can anyone enlighten me on the use of AAMI HE-74?

L

LiamD

Can anyone enlighten me on the use of HE-74?

I see references to other standards related to Usability and Human factors - 60601-1-6, 62366-1, HE-75. But there is limited reference to HE-74.

How does HE-74 fit into Medical Development on both EU and US?

Thanks,
Liam
 
L

LiamD

Is there nothing more formal than a slide in a presentation from Abbott? Perhaps from the FDA or a test house?
 
J

Jean_B

Trusted Information Resource
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Can anyone enlighten me as to what exactly Cm / Cmk are? Statistical Analysis Tools, Techniques and SPC 1
D FDA combo product-need to define direct & indirect impact regarding safety,quality & regulatory.Can anyone point me in right direction-SupplierMgmt 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Anyone using a GOM ATOS Scanbox 3D Vision System? General Measurement Device and Calibration Topics 0
V Anyone have templates for FDA GMP Guidelines for supplement manufacturers? US Food and Drug Administration (FDA) 0
A Has anyone implemented the Adobe Acrobat Sign Validation Pack to be 21 CFR Part 11 Compliant? ISO 13485:2016 - Medical Device Quality Management Systems 9
R Does anyone know how ASQ exam requirements are verified? Professional Certifications and Degrees 3
B Does anyone copyright their internal QMS documents? Document Control Systems, Procedures, Forms and Templates 24
Sam.F Anyone knows velocity 360 training Training - Internal, External, Online and Distance Learning 11
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
S Has anyone had experience with Intellect eQMS? ISO 13485:2016 - Medical Device Quality Management Systems 1
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 2
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 5
L Did anyone hear business registration ontario? General Information Resources 1
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
A Can anyone explain UKRP guidance relating to Northern Ireland? UK Medical Device Regulations 2
L Is there anyone joined Qserve's trainings? EU Medical Device Regulations 0
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
Ed Panek Is anyone familiar with Article 60 Certificate of Free Sale EU Medical Device Regulations 6
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 6
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
S Anyone Familiar with "SPC for Excel" add-in? Lean in Manufacturing and Service Industries 4
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 4
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
Dobby1979 FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
T Is anyone working with N299.1 (Supply/service to nuclear power plants)? Various Other Specifications, Standards, and related Requirements 0
GreatNate QMS in SharePoint - Is anyone doing this? Manufacturing and Related Processes 13
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 13
G Anyone working with or planning to do business in the CBD (cannabidiol) industry? US Food and Drug Administration (FDA) 1
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6

Similar threads

Top Bottom