SBS - The best value in QMS software

NOC - What is considered a "design change"

Udirn1

Starting to get Involved
#1
Dear All,
I have a question of what is considered as a "design change".
I have a cleared MDD device, and I would like to add another name to it, and for that I would need to issue NOC to our NB as a non significant change.
The main changes from the "father" model and "son model" would be in its given name, color , screen size and power supply output capabilities. (higher rating to support future applications).
In addition to that, there are some changes that I would like to consult with you if they are considered as "design change".
1. a Host board which supplies voltages to the CPU and support the bigger screen size ( a different module with same functionality as previous one:
2. Components on the Main board with higher ratings and support capabilities than their predecessors, but under the same basic design.(for future support)

Both devices have the same intended use, functionality, claims ect.
Thanks
Udi
 
Elsmar Forum Sponsor

Ron Rompen

Trusted Information Resource
#2
Definitely NOT an expert on medical devices, however my $0.02 is that the scope of the changes you are planning do constitute a design change, particularly with the modification of the power supply output capabilities. The host board and other component change on the main board would also fall into this 'group'.

Don't go only by my opinion though - there are other members here who are FAR more familiar with this topic.
 

yodon

Staff member
Super Moderator
#3
I think @Ron Rompen nailed it! In fact, all of those changes (maybe except color) have bearing on the risk file as well. The changes described in item #2 would also likely require a new round of 60601-1 compliance testing. And the 'son' product will need its own UDI, I'm sure.
 

William55401

Involved In Discussions
#4
A Design Change generally relates to changes to Design History File deliverables including the Risk Management File. If you say revise the power supply output, have you traced through the entire development cycle and determined impact on Design Inputs, Design Outputs, V & V, and Transfer? What documents must be updated? Orgs tend to run new product development very well. Orgs that are learning see the benefit of a Design Change Plan that identifies the impact (or not) to each of these areas. A key deliverable is a Reg Affairs impact? Are filings impacted? A well executed Design Change delivers the modified device while keeping your documents current.

One watchout. Be careful about calling inspection documents as part of the DHF (and in turn a Design Change trigger). HTH. Have fun. Enjoy the ride.
 
Last edited:
Thread starter Similar threads Forum Replies Date
Q Guidance on obtaining NOC from CDSCO India Other Medical Device Regulations World-Wide 2
D How to obtain NOC from DCGI (Drug Controller General of India) for importing drugs Manufacturing and Related Processes 6
D CB and customer audits considered as internal audits? General Auditing Discussions 9
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
D CE Marked product considered a Drug in India Other Medical Device Regulations World-Wide 0
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
S Is any dissatisfaction over a Medical Device considered as a complaint? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Are mortuary/autopsy tables considered to be medical devices EU Medical Device Regulations 7
K AS9100D Clause 7.5.2.a) - What is considered to be "documented information"? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
V Which batches should or could be considered for design validation and design verification? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
S Tools and equipment provided by customer - Considered as external provider? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S What is considered the complete software medical device? Medical Information Technology, Medical Software and Health Informatics 6
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Are EEG electrodes considered as one applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Can a Attribute Study be considered a Visual Inspection? Reliability Analysis - Predictions, Testing and Standards 6
M What is considered an "Audit Day" for OASIS AEA application? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
K What can be considered a "Post Delivery Activity" (ISO 9001:2015 Clause 8.5) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
C What is considered a "Critical" Raw Material? (Re: DNA Synthesis) Misc. Quality Assurance and Business Systems Related Topics 3
F Is Training Material Considered Labeling - FDA 21 CFR 801 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C DFAR 252.225-7008 - Is aluminum, say T6061, considered specialty metal (i) steel? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
I What are considered next generation ITSM tools? IT (Information Technology) Service Management 1
J Can a Surge test fail to a test level and still considered as Compliant? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Y Which version of ISO 13485 would be considered for MDSAP certificate? Canada Medical Device Regulations 8
L AIs the R&R study a training evidence considered ? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
C When is a device considered "sold to the general public?" Canada Medical Device Regulations 2
M Is Pain considered Harm in ISO 14971? ISO 14971 - Medical Device Risk Management 11
F Can be several measurement in a repl considered as nested factor in Minitab analysis Using Minitab Software 14
J Can some measurements be considered information only and not need calibration? General Measurement Device and Calibration Topics 7
M Is a computer used in hospitals considered a medical device? ISO 13485:2016 - Medical Device Quality Management Systems 17
S Are Polyethylene-folie gloves considered Medical Device ? EU Medical Device Regulations 4
T Has anyone considered what logic is? Coffee Break and Water Cooler Discussions 23
D Identification and Traceability 7.5.3 - What is considered Traceable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J Is Metals Analysis of Water Samples considered "sampling"? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 15
J Is painting considered a Special Process as defined by ISO 9001 7.5.2? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E Extent of modification to be considered as Modified Adoption Other ISO and International Standards and European Regulations 1
R How much Protective Current Rating of Building Branch Circuit should be considered? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
O Is this considered Design and Development in ISO9001? Mushroom Farming ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V What are Basic Dimensions about and why are they considered basic? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A Outsourcing Records Storage - Compliance Aspects to be considered during Audits Document Control Systems, Procedures, Forms and Templates 7
R Is foreseeable misuse considered as single fault condition? IEC 60601 - Medical Electrical Equipment Safety Standards Series 33
I Are KPIs (Key Performance Indicators) considered as Quality Objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R Should Nurse Call Systems be considered as ME Equipment or System? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
sagai New Draft Guidance from FDA - Factors considered for Risk/Benefit Determination Other US Medical Device Regulations 4
sagai What is CD writing considered as - for Device-Only SW? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Is Ship Test considered Design Verification or Design Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Are Heart Rate Monitors used in Wellness Environments considered Medical Devices? EU Medical Device Regulations 13
M IEC EN 60601-1-8: Battery monitor considered an alarm? IEC 60601 - Medical Electrical Equipment Safety Standards Series 12

Similar threads

Top Bottom