Software Documents in 510(k) submission (Moderate Level Concern)

L

luloo117117

#1
Table 3. Documentation Based on Level of Concern (cited from FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices)

For Moderate Level Concern, the following documents need to be provided.

Level of Concern
Software Description
Device Hazard Analysis
Software Requirements Specification (SRS)
Architecture Design Chart
Software Design Specification (SDS)
Traceability Analysis
Software Development Environment Description
Verification and Validation Documentation
Revision Level History
Unresolved Anomalies (Bugs or Defects)


I am not sure how detail of the software related documents should provided. Do we need provide the voltage signals table with the Pin# on the PCB Control board?
 
Last edited by a moderator:
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
I presume the reason there hasn't been a reply on this is that the question is unanswerable. Nobody can tell you what level of detail is required or, specifically, if the voltage signal tables need to be included.

Take a step back and consider what the guidance is trying to do: ensure safety of the patient or operator. If you have a moderate level of concern, then there's a chance the patient or operator could be injured. Now, does the act of documenting voltage signal tables prevent injury? No; however, the act of documenting the data and reviewing it and getting the right people to approve it might. Further, having it properly documented may minimize the risk of introducing an error (or potential for harm) in future revisions.

So it's up to your organization to determine the level of detail. Do what makes sense for your business (keeping in mind that the idea is to prevent injuries now and in future revisions). It's not been my experience that an FDA inspector will drill down to a particular voltage level on a particular pin; instead, they will try to determine if the information you do have is providing sufficient support to ensure patient safety and that you are in control of the design.
 
Thread starter Similar threads Forum Replies Date
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
G QMS Quality Plan Documents Software Document Control Systems, Procedures, Forms and Templates 4
I IVDD - Software and Graphics Standards or Guidance Documents EU Medical Device Regulations 3
S Special 510k Operating System for Data Management Software Design Documents IEC 62304 - Medical Device Software Life Cycle Processes 5
E Software that will manage my APQP documents Quality Assurance and Compliance Software Tools and Solutions 9
P Software to automate the completion of FAA documents 8130-9 or -3 automation Federal Aviation Administration (FAA) Standards and Requirements 6
J Control of Obsolete Documents - Changing document control software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R TS 16949 Audit Software - Documents and Templates IATF 16949 - Automotive Quality Systems Standard 6
N Should software be controlled in the same manner as documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
R Document control of software? Software packages that produce documents Document Control Systems, Procedures, Forms and Templates 4
L What is the 'State of the Art" Software for Management of Documents Quality Assurance and Compliance Software Tools and Solutions 2
A CMMI 3 - Software - Where we have to save all these documents Software Quality Assurance 4
F Gage R&R - Suggestions on gage R&R software or documents? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
Q Global change software where changing one document changes all documents Quality Assurance and Compliance Software Tools and Solutions 1
D Moving to a new software to control all of our documents and drawings Document Control Systems, Procedures, Forms and Templates 6
S Sub-contracting software documents - How to document? Document Control Systems, Procedures, Forms and Templates 4
D ISO Documents software - How do you control your ISO documents? Quality Assurance and Compliance Software Tools and Solutions 19
M Manufacturing Software + Controlled Documents Document Control Systems, Procedures, Forms and Templates 10
T Software for Electronic Documents Document Control Systems, Procedures, Forms and Templates 3
J Control of Electronic Forms and Documents Embedded in Software Document Control Systems, Procedures, Forms and Templates 12
J Seeking Advice - Effective QMS Software for Controlling Audits, Documents etc.? Quality Assurance and Compliance Software Tools and Solutions 19
D Software Registration GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Quotation software or spreadsheet Contract Review Process 2
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 1
T Wanted: Software for Developing Front-end Interfaces to (SQL) Databases Quality Tools, Improvement and Analysis 1
M Software "Nonconformances" ISO 13485:2016 - Medical Device Quality Management Systems 20
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0
J Document Control of Online Management Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Functionality of software in countries with different legal requirements IEC 62304 - Medical Device Software Life Cycle Processes 2
J Using an online software to maintain your QMS Quality Assurance and Compliance Software Tools and Solutions 7
R Quality System Software AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
V Software license key regulatory requirements Medical Information Technology, Medical Software and Health Informatics 2
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
M Software Validation SAP B1 for ERP ISO 13485:2016 - Medical Device Quality Management Systems 2
P Computer Software Assurance Software Quality Assurance 2
P Software validation for FPGA Software Quality Assurance 1
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
G Software verification vs. system verification IEC 62304 - Medical Device Software Life Cycle Processes 3
S Process Monitoring using SPC software Quality Assurance and Compliance Software Tools and Solutions 6
J Megger MIT520/2 adjustment software? Calibration and Metrology Software and Hardware 0
M Product Acceptance Software (PAS) PROCEDURE (BOEING D6-51991) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M 3D Scanner Software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
Y Software to Manage IEC 62304 Traceability Requirement IEC 62304 - Medical Device Software Life Cycle Processes 3
T Software item classification and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 4
T Software Unit definition - IEC 62304 - Medical Device Software Life Cycle Processes 3
T Software user interface - definition of hazards ISO 14971 - Medical Device Risk Management 15
T Classification Accessory Software medical device EU Medical Device Regulations 4
G Software Medical Device Classification EU Medical Device Regulations 7
D Software Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 10

Similar threads

Top Bottom