Cloud Connected Medical Device

DanBOS

Registered
#1
We are developing a medical device with:

A. On-device software (incl. touchscreen controls), as well as,
B. Cloud software that allows certain device operations to be performed remotely.

The device will be built by a contract manufacturer, who will also load the on-device software. We will be responsible for - 1) developing and deploying the cloud software, and, 2) Providing updates to the on-device software (OTA or providing customers with USB sticks).

My question is --> Do we register as a specification developer or a manufacturer with the FDA?.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
Y Exporting data to the cloud is a "Significant Change"? EU Medical Device Regulations 5
Tagin Hosting in the cloud still requires DR (OVH fire) Business Continuity & Resiliency Planning (BCRP) 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
B Oracle Cloud ERP Validation during Quarterly Patch ISO 13485:2016 - Medical Device Quality Management Systems 1
P Testing cloud-based backups IT (Information Technology) Service Management 7
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
O ZenQMS cloud solution? Quality Assurance and Compliance Software Tools and Solutions 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 3
was named killer CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED Document Control Systems, Procedures, Forms and Templates 5
S Validation of eQMS - Cloud based out of the box solution Other Medical Device Related Standards 18
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
S Moving from client-server to cloud-based, is that a new submission? Medical Information Technology, Medical Software and Health Informatics 3
Z Security for Approvals - Cloud based Complaint, NC, and CAPA systems Qualification and Validation (including 21 CFR Part 11) 8
T QMS - Documentation Cloud Storage EU Medical Device Regulations 0
R Validation of mobile app and cloud servers for data security IEC 62304 - Medical Device Software Life Cycle Processes 4
S Saving QMS documents in cloud drive - Compliance with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
T FDA proposed labeling standalone software cloud based US Food and Drug Administration (FDA) 4
R Online / Cloud Based Software as Medical Device EU Medical Device Regulations 8
S Cloud-Based Stand Alone Software - Software Medical Device (Class II) US Food and Drug Administration (FDA) 2
C Validation of Applications in a Cloud, CFR 21 part 11 (Environmental Monitoring) Other US Medical Device Regulations 3
D Anyone using a cloud based QMS software? Document Control Systems, Procedures, Forms and Templates 12
E Cloud Services for Medical Devices with CE Mark EU Medical Device Regulations 5
Q File Management system in Cloud for Medical Mobile Apps IEC 62304 - Medical Device Software Life Cycle Processes 2
D Can Cloud Data Management resources be qualified? Should they be? Quality Manager and Management Related Issues 3
R Cloud Computing Requirements for Design History Files for Software Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Marc Anyone here affected by the volcano ash cloud? April 2010 Travel - Hotels, Motels, Planes and Trains 33
Jen Kirley What's procedurally required for "cloud computing"? TS16949 Clause 4.2.4. Records and Data - Quality, Legal and Other Evidence 8
K Definition Point-Cloud Data - Understanding of the term "Point-Cloud Data" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
Marc Biggest Wi-Fi Cloud Is in Rural Oregon After Work and Weekend Discussion Topics 4
R Point Cloud Technology Validation - Point Cloud to CAD model comparisons for FAIR General Measurement Device and Calibration Topics 2
A Metal Enclosure Connected to PCB Ground for ESD Reasons IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
A Hospital IT expectations for connected medical device using WIFI Medical Information Technology, Medical Software and Health Informatics 0
S Development of 2xMOPP galvanic isolator for USB-connected device IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
S Defibrillator Requirement for ME Equipment connected to HF Electrosurgical Generator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Marc Will you have an Internet Connected (IoT) Toilet? Coffee Break and Water Cooler Discussions 7
thisby_ Medical Device Battery Powered Equipment connected to Charger IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D One Company divided into two but connected by a Physical Pipeline Registrars and Notified Bodies 6
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
dgrainger Informational Consultation on the future regulation of medical devices in the United Kingdom UK Medical Device Regulations 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 3
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
V Taiwan - Veterinary medical devices Other Medical Device Regulations World-Wide 1
K System of medical devices EU Medical Device Regulations 0
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
D Dental application - medical product or not? Other US Medical Device Regulations 8

Similar threads

Top Bottom