Mobile Medical Device for MDD - Medical Image Viewer

cmeby

Involved In Discussions
#1
Hello all
I am having trouble finding any guidance documents for MDD around the subject of Mobile Device.
Our Medical Image Viewer is classified along with PACS as class I.

Is we want to use for mobile does this make it Class IIa or change the classification at all?

The FDA came out with a guidance and Health Canada has some regulations around this...does MDD?

Thank you in advance for some insight.
 
Elsmar Forum Sponsor

c.mitch

Quite Involved in Discussions
#3
Hello cmeby,

There's nothing about mobile medical devices in the MDD and in the guidances, so far.
An english non profit organization issued a white paper about health apps: http://blog.d4.org.uk/2012/01/regulation-of-health-apps-a-practical-guide.html
I think this is the most recent state of the art in EU but it is abolutely not official.
Otherwise you can rely on FDA draft guidance on mobile medical apps.

IMHO, the class doesn't change with the fixed/mobile criteria. You only add technical risks of connection loss, cyber threats but you don't change the intended use.

Regards,
Mitch.
 
Thread starter Similar threads Forum Replies Date
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
S Medical device mobile app UDI - Where is the UDI labelled? Other US Medical Device Regulations 1
E Wearable Medical Device & Mobile Apps in US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Wearable Medical Device & Mobile Apps in EU EU Medical Device Regulations 1
S Do you test the download and installation of a mobile medical device app? Software Quality Assurance 6
C Mobile Application which collects Physiological Data from a Medical Device Other Medical Device and Orthopedic Related Topics 1
E Medical Device supplemented with a Mobile Application IEC 62366 - Medical Device Usability Engineering 4
J Mobile Medical Device App Validation Guidance vs. GPSV? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Regulation Approach on Mobile Application which is Medical Device Acccesory EU Medical Device Regulations 1
P SOUP anomaly evaluation for MMA (Mobile Medical Application) IEC 62304 clause 7.1.3 IEC 62304 - Medical Device Software Life Cycle Processes 4
M Challenges Incorporating Mobile Devices into Medical Devices Other Medical Device Regulations World-Wide 1
A End of Life for Medical Mobile App (Stand Alone Software) Medical Information Technology, Medical Software and Health Informatics 5
Q File Management system in Cloud for Medical Mobile Apps IEC 62304 - Medical Device Software Life Cycle Processes 2
Ajit Basrur FDA issues Final Guidance on Mobile Medical Apps (Applications) US Food and Drug Administration (FDA) 2
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Medical Application Classification in Controlled/Uncontrolled by Mobile App State. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
sagai Mobile Medical Applications Final Guidance Released Other US Medical Device Regulations 0
M Mobile Medical Platforms - How to deal with Supplier Hardware/Software Changes? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S FDA Draft Guidance on Mobile Medical Applications US Food and Drug Administration (FDA) 1
bio_subbu FDA issues first draft guidance document on Mobile Medical Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 2
JoCam Mobile Patient Hoists and Electrical Testing Other Medical Device Related Standards 0
R Validation of mobile app and cloud servers for data security IEC 62304 - Medical Device Software Life Cycle Processes 4
G Alternatives to time apps (mobile applications)? Coffee Break and Water Cooler Discussions 3
S Mobile app data privacy - Length of record retention in a software app Medical Information Technology, Medical Software and Health Informatics 1
S ISO 17025 Requirements for Mobile On-site Calibration ISO 17025 related Discussions 2
S In a risk analysis, how can we tie mobile app security breach to ISO 14971? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Ranking Changes for Non-"Mobile-Friendly" Sites Forum News and General Information 10
R Mobile Auto Valeting Services - Waste Disposal (Environmental Perspective) Miscellaneous Environmental Standards and EMS Related Discussions 3
M Portable/Mobile Washer, Laundry Reviews Coffee Break and Water Cooler Discussions 2
W FDA's final guidance for Mobile App will final in coming weeks. Medical Information Technology, Medical Software and Health Informatics 0
I Mobile Equipment - Six label printer to be used in different areas Qualification and Validation (including 21 CFR Part 11) 4
S Mobile Phone based Diabetes Monitoring Technology Medical Information Technology, Medical Software and Health Informatics 2
R How to conduct the Threshold Test of Mobile Equipment specified in 3rd edition? IEC 60601 - Medical Electrical Equipment Safety Standards Series 35
B What is the difference between Mobile and Portable? Other US Medical Device Regulations 9
Marc Oscar-Mayer Weiner Mobile - West Chester, Ohio 2PM 29 March 2011 Coffee Break and Water Cooler Discussions 16
A Mobile Touchscreen Devices in a Manufacturing Environment Manufacturing and Related Processes 11
W Mobile equipment qualification? Manufacturing and Related Processes 1
I Employment Contract Review - Categories of International Mobile Workers Contract Review Process 1
D Need suggestions for a mobile Spectrophotometer (a.k.a. color meter) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K CE Marking for Mobile Air Compressors driven by a Diesel Engine CE Marking (Conformité Européene) / CB Scheme 2
kisxena 510(k) filing for GSM (Global System for Mobile Communication) technology? Other US Medical Device Regulations 9
Marc What 'mobile' used to mean After Work and Weekend Discussion Topics 6
ScottK Been getting phone calls on my mobile with a single digit area code? (USA) After Work and Weekend Discussion Topics 7
V Testing Mobile Platforms - How to write automations for mobile GUI testing Software Quality Assurance 0
C Learning Curves - Biggest Process "VARIABLE" is mobile workforce ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
M ISO certified Mobile Telecommunications Operators ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 0
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom