Documentation and Submission Deliverables for Medical Device Software

#1
Does anyone have a Word table or Excel file that provides the documentation required for an FDA pre-market submission (510(k) or PMA), including a comprehensive potential list of deliverables. I know that this exists in the FDA Guidance, but it does not include a list of deliverables.

I don't know if this has evolved in the last year or two with the 2015 amendment to IEC 62304, and considering the Guidance is from 2005.

Also, do you know if there is a Standard or Guidance that relates to medical device software that will connect to the "cloud". The closest I could come was IEC/TR 80001-1 Application of risk management for IT Networks incorporating medical devices, but I don't think that would be correct.

Thanks.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
FDA recognizes both 62304:2006 and amendment 1 (2015) so if you follow one of those, you will have the documentation expected.

The FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm) also lists expected documentation based on (documented) level of concern, you would be compliant. It lines up pretty well with 62304 but I think 62304 is more comprehensive so if you follow that, you're probably in better shape.

The biggest change in 62304 Amd 1 is the recognition of legacy software and how to deal with it. Personally, I think Amd 1 is an improvement and closes a few concerns so I would recommend that.

Not aware of any guidance on software in / connecting to a cloud. You're on the right track, though, with the risk-based approach.
 

mihzago

Trusted Information Resource
#3
As Yodon said, the FDA guidance on the software submissions is the document that defines the content of the 510(k) for software. The guidance and IEC 62304 both use level of concern, and while the match up for the most part, make sure you answer both sets of questions.

Another guidance you want to review is the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which applies to any networked device, including software connecting to a cloud.
 
Thread starter Similar threads Forum Replies Date
H Do you repeat information throughout your documentation submission? EU Medical Device Regulations 4
V PPAP documentation - Submission required in English APQP and PPAP 3
D Documentation Requirements for Firmware in a 510(k) Submission Other US Medical Device Regulations 1
V 510(K) Cyber Security Documentation for Pre-market Submission (Templates) Other US Medical Device Regulations 6
I Secured Documentation Submission and Nondisclosure Agreements Document Control Systems, Procedures, Forms and Templates 4
T 510k Submission - Where to describe firmware and firmware design documentation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
G The Documentation of Data Analysis for an ISO 13485 Medical Device Submission ISO 13485:2016 - Medical Device Quality Management Systems 9
D Recall Documentation - Recall Submission vs. Recall Notification US Food and Drug Administration (FDA) 4
O Project Documentation Submission Guidelines for Real Estate Construction Document Control Systems, Procedures, Forms and Templates 4
J Advice on documentation for project I am working on... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
H Characteristics related to safety - format of documentation ISO 14971 - Medical Device Risk Management 2
J How many hours for a NB to review Technical Documentation? EU Medical Device Regulations 6
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
A Technical documentation ce marking pippete tips CE Marking (Conformité Européene) / CB Scheme 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
I "Usability" for technical documentation EU Medical Device Regulations 1
Azaarus Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 10
E Technical documentation for IVDD General/ other CE Marking (Conformité Européene) / CB Scheme 3
B ISO13485 Standard Documentation Packages ISO 13485:2016 - Medical Device Quality Management Systems 2
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Z Data sheet from McMasterCarr enough for RoHS/REACH documentation? REACH and RoHS Conversations 4
K Addressing Missing Documentation Document Control Systems, Procedures, Forms and Templates 7
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
NDesouza COTS Items CoC for FAI Documentation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
C Documentation hold during submissions? ISO 13485:2016 - Medical Device Quality Management Systems 0
K SOUP (Software of Unknown Provenance) Anomaly Documentation IEC 62304 - Medical Device Software Life Cycle Processes 2
C Gobys for operations documentation plan Oil and Gas Industry Standards and Regulations 4
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
was named killer CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED Document Control Systems, Procedures, Forms and Templates 5
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
K ITAR Visitor Documentation of Citizenship AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
A Process Documentation for ISO 9001:2015 Internal Auditing 2

Similar threads

Top Bottom