MDR question - Meaning of Stability

Download Free White Paper
Elsmar Forum Sponsor
E

EmiliaBedelia

Involved In Discussions
#2
#2
Stability generally means the ability of the product to continue to meet its intended purpose over its intended lifetime.
In the context of measuring function, I would think of considerations like, are the markings going to wear off? does the temperature sensor have a lifetime of use that it will be valid for? is there a need for calibration or maintenance?
 
Steve Prevette

Steve Prevette

Deming Disciple
Leader
Super Moderator
#5
#5
I agree that stability is performance over the life of the instrument, and also closely related to predictability. One example may be that I take the instrument into calibration and determine it is within limits but has drifted downwards and needs to be tweaked. If over many times of performing calibrations, and it is always drifting downwards between cals, I might invoke that the instrument is not "stable". A good way to identify stability is to plot calibration results over time on a control chart.
 
CharlieUK

CharlieUK

Quite Involved in Discussions
#6
#6
A wearable thermometer would be exposed to a much wider range of temperatures than, say, a large piece of equipment used in a medical centre, so it would be important that it's performance was also stable over temperature as well as time
 
Ronen E

Ronen E

Problem Solver
Moderator
#7
#7
CharlieUK said:
A wearable thermometer would be exposed to a much wider range of temperatures
Click to expand...
This was supposed to have fed into the Design Inputs through the initial Intended Use (e.g. use environment) and through Risk Management, taking account of extreme conditions and foreseeable misuse.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Question on MDR classification EU Medical Device Regulations 5
C MDR - Question around software accesories EU Medical Device Regulations 2
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 4
C Revising a DoC for a legacy device under MDR/IVDR transitional periods EU Medical Device Regulations 4
D MDR literature review on device without clinical claims EU Medical Device Regulations 7
B EU MDR transitional period extension EU Medical Device Regulations 4
I Classification of device per Annex 8 of the EU MDR EU Medical Device Regulations 4
R Class I devices in the extended MDR transition period EU Medical Device Regulations 17
A MDR- Technical Documents EU Medical Device Regulations 4
P Distribution of "CE" Declaration of conformity under MDR EU Medical Device Regulations 3
E Expired CE with no pending MDR certification EU Medical Device Regulations 4
T SaMD labeling requirements - MDR IEC 62304 - Medical Device Software Life Cycle Processes 3
L Annex of ISO 13485:2016 as harmonized standard (MDR/IVDR) ISO 13485:2016 - Medical Device Quality Management Systems 2
P MDR Reporting Requirements for Devices Already covered in a correction under 21 CFR 806 US Food and Drug Administration (FDA) 0
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
G MDR CE Expiration Date EU Medical Device Regulations 4
C MDR vs CMDR EU Medical Device Regulations 4
O MDR language requirements EU Medical Device Regulations 12
K Whether the product is an accessory according to the MDR definition EU Medical Device Regulations 3
L Adverse Event Reporting Flowchart (MDR EU) EU Medical Device Regulations 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
Ed Panek MDR Delay? EU Medical Device Regulations 2
dgrainger Informational Proposal to address MDR challenges EU Medical Device Regulations 23
goldenguo MDR/IVDR Insurance and Liability for Manufacturers, EU Representative and Importer EU Medical Device Regulations 3
B MDR PSUR versus Canadian Summary report EU Medical Device Regulations 4
C MDR 2017/744 Article 22 EU Medical Device Regulations 3
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
D EU MDR Derogation EU Medical Device Regulations 0
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
M On-demand EU MDR Compliance toolkit with online training courses, templates & document management system Training - Internal, External, Online and Distance Learning 0
M EU MDR (GSPR Checklist) consolidated with TGA EP Checklist EU Medical Device Regulations 5
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 8
H MDR clinical evaluation EU Medical Device Regulations 0
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
N Adding New Products during MDR transition period Manufacturing and Related Processes 1
L Internal Audits during the MDR Transition Period EU Medical Device Regulations 5
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
S OEM- Virtual Manufacturer contract MDR Quality Management System (QMS) Manuals 0
J TGA CER & EU MDR CER Requirements for Australia Other Medical Device Regulations World-Wide 3
G MDR DRAFT DoC EU Medical Device Regulations 7
F MDR Distributor EU Medical Device Regulations 6
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
M Declaration of conformity MDR EU Medical Device Regulations 10
dgrainger Informational Manual on Borderline for MDR/IVDMDR EU Medical Device Regulations 6
G MDR Requirements for Samples EU Medical Device Regulations 5
C Applicability of classification rule 9 under MDR EU Medical Device Regulations 6

Similar threads

Top Bottom