Hardware and OS Responsibility in FDA

K

kingkobra

#1
We are making a software application ,

we have following questions about the hardware and OS resposibilty as a manufacturer .

1) do we (Manufacturer) own the responsibility of Hardware and OS ? becasue as we dont have manufacured them (For example they are manufactured by windows or say HP).

2)Since the hardware and OS are closed-source and proprietary, how does the manufacturer determine and mitigate the risks?

3) What documentation needs to be submitted to FDA for the HW and OS risks?

Thanks in advance
 
Elsmar Forum Sponsor
K

kingkobra

#3
Well , we are working as a third party helping a company for getting details , I'll be thankful if you give the details in both cases .
 

yodon

Staff member
Super Moderator
#4
Sagai's question is valid and needs to be addressed.

But there are some things to consider. You will test (verify) the application under certain conditions; e.g., hardware configuration (amount of memory, processor speed, etc.); OS configuration (revision / patch level); etc. These need to be documented as part of the overall device configuration and use instructions.

If there is any other software in the system ("COTS" or "SOUP" - which includes things like browsers) then those would have to be addressed as well).

Part of your risk assessment will be to ensure that your application is appropriate for the hardware and OS configuration. This is where Sagai's question is quite relevant. If you have control over the hw and sw (OS) then you can limit the scope; otherwise, you may have to take more extraordinary measures to ensure safe and effective operations on a variety of platforms.

The product risk assessment can also help. For example, if you have security concerns and utilize system services to implement controls, this would be included in your verification.
 
K

kingkobra

#5
Thanks yodon for your help .

will that(Risk Control) be the part of submission process ? if yes , is there any list given by FDA that specifies the those "certain conditions" you have mentioned? I mean how will I know which tests should I perform ?
 

sagai

Quite Involved in Discussions
#6
I really have nothing to add to the things that Yodon already mentioned.
I think the risk management file is one of the key thing to be submitted regardless FDA may state otherwise based on the level of concern. Highly likely they may ask it later anyway.
There is one guidance I would advise to look into:
http://www.fda.gov/downloads/medica...onandguidance/guidancedocuments/ucm089593.pdf

Other than that, I would use iso14971 and its guidances like AAMI TIR32:2004 and ANSI/AAMI/IEC TIR80002-1:2009.
Cheers!
 

yodon

Staff member
Super Moderator
#7
I mean how will I know which tests should I perform ?
Indeed, that's the hard part! (And why the consultants get paid the big bucks :) )

Ideally, it's all a natural flow-down from your top level specifications. (We need to do x so we have to have a system that has the following configuration: a, b, c... Or from a risk perspective: if the system fails because of j then bad stuff can happen so we'll add the following controls to minimize the likelihood of j occurring: k, l, m...).

It's not something anyone in a venue like this could give much specific help. About all I could say at this point would be to let the requirements and risk assessment (controls) guide the effort. (And really, if you show that your requirements are complete and thoroughly verified, you'll probably be in good shape when the FDA comes a-calling).

Sorry I can't offer more help but this is product-specific systems engineering stuff. Hopefully there are folks on your team that can address these things.
 
Thread starter Similar threads Forum Replies Date
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 12
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
W Air Quality Measurement Hardware and Software General Measurement Device and Calibration Topics 11
A Components of a medical device - Hardware robotic hand EU Medical Device Regulations 3
B Documenting hardware on Form 2 of AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Validation of Medical Device Hardware containing Software - How many to Validate ISO 13485:2016 - Medical Device Quality Management Systems 1
S Mammography standards or regulations for radiology software (no hardware)? Other Medical Device and Orthopedic Related Topics 0
C PCBA Hardware Component different failure types - How to rate detection? FMEA and Control Plans 8
P Software requirement and design specifications - Medical device contains both hardware and software IEC 62304 - Medical Device Software Life Cycle Processes 2
N Configuration Management - Physical Audit and Functional Audit for Software and Hardware General Auditing Discussions 4
C Supplier Assessment for Hardware supporting SaMD ISO 13485:2016 - Medical Device Quality Management Systems 1
M Missing Hardware in Accessory Kits Manufacturing and Related Processes 5
J Hardware Receiving Inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
S Testing software-only device on hardware - What are the hardware parameters? Software Quality Assurance 6
C Aerospace Hardware Revision Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Finding a hardware supplier/distributor compliant with RoHS RoHS, REACH, ELV, IMDS and Restricted Substances 1
N Specifying a MINITAB PC Hardware - What matters? Using Minitab Software 2
E Hardware (Such as Rivets and Bolts) - Chemical and Physical Test Reports AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
T Necessary test documents for Class II Medical Device Hardware and Firmware ISO 13485:2016 - Medical Device Quality Management Systems 9
V What are the criteria for determining extent of requalification (hardware upgrade) ISO 13485:2016 - Medical Device Quality Management Systems 2
S Use of Non-Medically Test Hardware in Medical Environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
K Use of off the shelf hardware in Medical Devices class II IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
S CMM Hardware - Renishaw Probe Magnetism question Calibration and Metrology Software and Hardware 8
R Triggering Root Cause Analysis for Hardware Returns Nonconformance and Corrective Action 3
F Traceability Requirements for Computer Hardware Equipment under ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
I Defining the scope for ISO 9001 Registration - Software, Hardware and Customer Care ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Assessing Process Capability on Variation (Hardware Adjustment Mean Shift) Capability, Accuracy and Stability - Processes, Machines, etc. 4
M Mobile Medical Platforms - How to deal with Supplier Hardware/Software Changes? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
michellemmm Hardware Design Standards - Printed Circuit Board Assembly EASA and JAA Aviation Standards and Requirements 2
B Optical Steel Surface Inspection System (best hardware to recommend) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
B J-STD-001DS Space Applications Electronic Hardware Addendum Certification Manufacturing and Related Processes 3
I Minitab 14 USB Hardware Key Availbility Using Minitab Software 7
K AS9100 Suppliers of Hardware, Fasteners, Washers, etc. - What standard to use? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Supplier Quality Investigation - Software and Hardware Issues Supplier Quality Assurance and other Supplier Issues 8
N Audit questions for software/hardware selling company Software Quality Assurance 17
N Internal Auditing - IT software hardware selling company Internal Auditing 5
C AS9102 Form 2 and Standard Hardware clarification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
U 1. Hardware Life Cycle; 2. Requirements tracking; 3. FMEA Risk Analysis ISO 13485:2016 - Medical Device Quality Management Systems 7
N What Defines Flight hardware? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
A DFMEA for Hardware (Automotive ECU with embedded software) FMEA and Control Plans 3
M Mil-Spec Hardware (MS, AN, NAS) Suppliers on AS9100 Approved Suppliers List AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
P Hardware Naming and Description issue - Is TAP BOLT an industry common term? Manufacturing and Related Processes 14
J AS9102 section 3 - Who can explain what ''standard catalog hardware '' means AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J AS9102 - Do I have to do FAI for all Standard Catalog Hardware items???? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
G What PC System (OS, Hardware, etc.) do you run? After Work and Weekend Discussion Topics 28
O GRR (Gage R&R) Method for Camera Vision Inspection System Hardware and Software Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
apestate Custom hardware product - What acceptable quality level (AQL) is expected in the US? AQL - Acceptable Quality Level 4
F Definition Test Hardware - "Comparative References such as Test Hardware" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
Q Private Labeler FURLS Responsibility-USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom