Cloud-Based Stand Alone Software - Software Medical Device (Class II)

S

SD1985

#1
Hi,

For a cloud-based stand alone software medical device (Class II), I was wondering how one would have DHR (Device History Records) as each user will have a user name and password to log on the same version of software which is hosted on the cloud. Each user would not get a CD or other physical device. Also, aside from deployment to the cloud, there would be no installation records...Any comments would be very helpful.
 

yodon

Staff member
Super Moderator
#2
Yeah, the DHR model doesn't fit all that well with stand-alone software.

Per the regulation, the DMR is expected to contain:
* device specifications - should be easy enough to cite
* production process specifications - gets a bit gray here but what do you do to control the binaries after build and into installation? Do you also have specifications for the system on which the software is installed?
* QA procedures - consider a configuration status accounting audit
* Packaging and labeling - none other than some version ID in the software
* Installation procedures - should have them

Then, the DHR - the evidence that you followed the recipe (DMR) includes:
* date of manufacture
* quantity mfg & quantity released (will be 1)
* acceptance records - do you do any post-install checks?
* ID & labeling - should be your software version number
* device ID / control (UDI)

You could encapsulate all this in a version description document (that also points to information about your build process, development environment, build [configuration] info, etc.)

You wouldn't need to drill down to the individual user names.

You mention no installation records. Why not? The regulation does require a record. How do you know it was installed correctly? How do you know the platform is suitable for the software? Shouldn't need to be much but it should be easy enough to capture a record.
 
S

SD1985

#3
Thank you, this was great info. When I stated installation records, I meant installation at customer sites. We will have deployment records (i.e., deploying the software to the cloud).
 
Thread starter Similar threads Forum Replies Date
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
P Testing cloud-based backups IT (Information Technology) Service Management 7
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
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 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
D Anyone using a cloud based QMS software? Document Control Systems, Procedures, Forms and Templates 12
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
B Oracle Cloud ERP Validation during Quarterly Patch ISO 13485:2016 - Medical Device Quality Management Systems 1
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
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
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
C Validation of Applications in a Cloud, CFR 21 part 11 (Environmental Monitoring) Other US Medical Device Regulations 3
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
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R X-RAY Based Diagnostic Veterinary medical Devices Medical Device and FDA Regulations and Standards News 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
M Reduce occurrence rating based on the PMS data and customer complaint data ISO 14971 - Medical Device Risk Management 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
Sidney Vianna IATF 16949 News Risked Based Audit Day Calculation IATF 16949 - Automotive Quality Systems Standard 2
S Annual Inspection Layout - Based on Customer print ? IATF 16949 - Automotive Quality Systems Standard 8
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
M Medical device substance based-leachables Other Medical Device Related Standards 2
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 17
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
P Conformity assessment based on a quality management system or production quality assurance EU Medical Device Regulations 3
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
B Do you use paper or web-based templates for CAPA processes? ISO 13485:2016 - Medical Device Quality Management Systems 3
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Tolerance definition based on expected Cp/cpk Reliability Analysis - Predictions, Testing and Standards 14
S Risk based internal auditing Internal Auditing 6
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
R Expected life span of Medical devices - X-Ray based diagnostic medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom