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

Leader
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
P Controls over Systems Documentation in 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 1
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
P AS9100D clause 8.6 - Documentation required to show evidence of conformity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
E Discussion: How do you split up your Technical Documentation? EU Medical Device Regulations 4
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
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
G Technical documentation for UKCA UK Medical Device Regulations 4
xfngrs Multi-lingual documentation IATF 16949 - Automotive Quality Systems Standard 6
R Configuration Management - Identifying Documentation IEC 62304 - Medical Device Software Life Cycle Processes 3
A Technical Documentation => Responsibilities when signing documents ISO 13485:2016 - Medical Device Quality Management Systems 7
A Update of Technical Documentation EU Medical Device Regulations 3
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
M Documentation accompanying an aerospace part AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
G Seeking reference guides/ documentation /tips on verification best practices Other Medical Device Related Standards 6
P MDR documentation submissions EU Medical Device Regulations 4
dubrizo Good Documentation Practice (GDP) as it Applies to External Contractors or Vendors Document Control Systems, Procedures, Forms and Templates 4
A Updating Technical Documentation regularly => Leaner Release Advice EU Medical Device Regulations 2
P Updates to Technical Documentation EU Medical Device Regulations 7
R Good Documentation practices SOP US Food and Drug Administration (FDA) 2
S Documents belonging to Technical documentation to be stored in one file or spread in the QM system? EU Medical Device Regulations 9
O MDD 93/42 and making documentation available EU Medical Device Regulations 1
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 3
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

Similar threads

Top Bottom