SBS - The Best Value in QMS software

Over The Air (OTA) updates for medical device

#1
Dear all,

I have heard that FDA is on its way to requesting that manufacturer will need to implement means to patch medical devices over the air.

When do you think this will become a regulation? How far are we?

The only legit article I could find comes from FDA´but it's not conclusive: Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health | FDA

Thank you in advance for you input.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I would think that a blanket statement like that to be a bit less than realistic. I think that would mean that every device would have to have a cell modem since you can't guarantee a network otherwise. That's going to drive costs up for one and it's impractical in many cases (implants!?!). Patches need to be coordinated by the end user. Can't have a patch applied in the middle of some procedure. And I think there still has to be someone at the end use site to ensure that the patch was successfully applied.

Interesting thought, though.
 
Thread starter Similar threads Forum Replies Date
D Air hood calibration ISO 13485:2016 - Medical Device Quality Management Systems 1
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
G We want to add Covid-2 /19 to our air filter 510 K Medical Device and FDA Regulations and Standards News 0
W Air Quality Measurement Hardware and Software General Measurement Device and Calibration Topics 11
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
E Employee complaining about air quality Occupational Health & Safety Management Standards 12
P HVAC System vs Air Handling Unit (AHU) - Differences Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
P Fan filter unit (un-ducted to air supply) vs fan filter unit (ducted to air supply) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
I Compressed air system qualification and 1 micron particle analysis Other Medical Device Regulations World-Wide 0
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
A Tubing Clog Tester - Convert from Air Bubble to Flow Rate Reliability Analysis - Predictions, Testing and Standards 1
triathlonx13 Leak test correlation - Bubble to Air Reliability Analysis - Predictions, Testing and Standards 8
I Process compressed air and contact with the product (ISO 8573-1:2010) Qualification and Validation (including 21 CFR Part 11) 0
S Performing PQ on a Small (tabletop) Air Heat Treating Oven ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Should Air Screwdrivers be Calibrated? General Measurement Device and Calibration Topics 15
N What does an effective design process look like? (shoots flare in the air) Design and Development of Products and Processes 2
R Measuring LiON Battery State of charge - Transporting batteries by Air RoHS, REACH, ELV, IMDS and Restricted Substances 1
R Air-powered dental handpiece with LED IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A 61010-1 Accessible Parts - Limit Values and Crepage and Air Clearance Distances Other Medical Device Related Standards 1
somashekar Is it a good practice to have Air Conditioner in the Gym Hospitals, Clinics & other Health Care Providers 2
S Is 0.1 micron monitoring required for ISO Class 5 Laminar Air Flow unit ? Other ISO and International Standards and European Regulations 4
M Regulations for oxygen/air-tubing and connectors inside of ME equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Setting air gauging outside of a part tolerance Capability, Accuracy and Stability - Processes, Machines, etc. 2
S Can Validation be done for fewer Air Changes than specified? Qualification and Validation (including 21 CFR Part 11) 6
Marc Air Pollution in the Early 21st Century Coffee Break and Water Cooler Discussions 5
C SOP for Door to Door Air Cargo Document Control Systems, Procedures, Forms and Templates 3
S What are air changes are required for ISO Class 8 Clean Room? US Food and Drug Administration (FDA) 2
V Validation Test and Acceptance Criteria for Compressed Air Qualification and Validation (including 21 CFR Part 11) 3
E Is Volumetric Air Sampling required for Class ISO 7 Cleanroom ? ISO 13485:2016 - Medical Device Quality Management Systems 1
B Searching for Naval Air Engineering Center test specification NAEC TP 83-1 Misc. Quality Assurance and Business Systems Related Topics 1
C Compressed Air coming into contact with Class II Medical Device Design and Development of Products and Processes 10
G Update Numerex Air Bearing CMM? Capability, Accuracy and Stability - Processes, Machines, etc. 6
kedarg6500 Should soft annealing of Copper be done using regular air or in an inert atmosphere ? Manufacturing and Related Processes 2
Jen Kirley Can a company with pending air license and water permit still get certified to 14001? REACH and RoHS Conversations 2
S How to determine the Air Clearance for Floated Secondary Circuit IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
N Is Air Burst test for oven treated condoms still required under ISO 4074? Other Medical Device Related Standards 1
R Creepage and air clearance under vacuum conditions IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Looking for Air Sampler Suggestions Manufacturing and Related Processes 4
S General Safety Question - Possibly fatal air embolisms caused by air hoses Human Factors and Ergonomics in Engineering 21
N PCB Creepage and Air Clearance on 8 Layer Boards IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R How to calculate the Air Flow Rate in clause 201.12.4.4.105 of IEC 60601-2-16:2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P Critical Limits for Air Blower as CCP (Critical Control Point) Food Safety - ISO 22000, HACCP (21 CFR 120) 6
I What class of Compressed Air (ISO 8573) for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P How to reduce or shut off Compressed Air for Painting Robots Manufacturing and Related Processes 3
AnaMariaVR2 24hr Worldwide Air Traffic Simulation Federal Aviation Administration (FAA) Standards and Requirements 0
S Air Line Devices Filters, Pressure Regulators, Lubricators Manufacturing and Related Processes 3
somashekar Mangoes ground Air India flight ~~~ Travel - Hotels, Motels, Planes and Trains 1
J Air Micrometer Basics - What are the internal parts and how do they work Manufacturing and Related Processes 7
V AHU (Air Handler Units) and Clean Room References Qualification and Validation (including 21 CFR Part 11) 3
B Compressed Air Validation Help! Qualification and Validation (including 21 CFR Part 11) 2

Similar threads

Top Bottom