SBS - The best value in QMS software

Help develop sampling plan for prototype samples (medical devices)

SGquality

Quite Involved in Discussions
#1
Hello everyone,

I need help on developing sampling plans for prototype samples and am looking for which valid statistical technique to use.
Please be kind on me as I am new to Statistics :)

Thank you
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Staff member
Super Moderator
#2
We need more information.
What are the prototypes - what do they do?
What are you testing for?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
OK but what do they actually do? and what will you be testing for?

sample sizes depend on many specific things. what defect rate are you looking to be under? is the device a single use device or is it a multi use instrument?
 

chris1price

Trusted Information Resource
#5
You need to consider the risk associated with the devices and of the testing. For verification of attributes I suggest looking at a binomial type model or the normal distribution for variable data. For both V&V make sure you justify the use of prototype very carefully.

These papers give good examples of the how the sample size can be determined.
Sample Sizes: How Many Do I Need? | 2014-07-07 | Quality Magazine
Statistical Sampling Plan for Design Verification and Validation of Medical Devices | IVT - JVT
 

SGquality

Quite Involved in Discussions
#6
Bev, these prototypes will be used to test the functional requirements of the device. For example, these prototypes are hearing aids and used to test various aspects of hearing aids for audio etc.
 

Mark Meer

Trusted Information Resource
#7
Bev, these prototypes will be used to test the functional requirements of the device. For example, these prototypes are hearing aids and used to test various aspects of hearing aids for audio etc.
I believe Bev replied to your inquiry in a different, related thread here. (see Post #9)
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#8
Sorry - two threads that are very similar:

I’m not an expert in hearing aids (my only exposure is that my wife wears them and I’m in charge of replacing the batteries).



Usually these things are not about some statistical calculation of the sample size, although that is important. It’s about understanding what constitutes the ‘population’.



In design verify, a re-usable device such as a hearing aid would have a smaller sample size of the device than a single use device. Sample size will still depend on what characteristics you need to verify.


Although some characteristics are deterministic - either it works or it doesn’t - some variation will have to be included. For example battery fit. Batteries have a specified size range and your design has a specified size range. At a minimum I would expect that you would need to ensure that the minimum and maximum battery size fits in the minimum and maximum specified sizes of your hearing aids. So the sample size is determined by counting the conditions to be verified.



Another example: I’m sure you have requirements regarding the wear of the battery compartment. How many battery changes are you targeting? that and your confidence level as well as the margin you need for your requirement will tell you the sample size – how many insertions do you need? Of course you could go to directed testing around stress vs strength that would not require actual insertions until validation with ‘production’ level parts.


Some characteristics are subject to inherent variation from use conditions: for example, I can imagine that you need to prove that the hearing aid meets output requirements given a range of sound volume and frequency as well as ‘fit’ in the ear? In this case your sample size is more dependent on the range of each condition than anything else. The number of devices is less important than the number of conditions. Do you just test at the extremes and the nominal? Or across the range in a distribution of conditions that is representative of the conditions that exist in actual use? It is also dependent on whether or not the hearing aid is consistent in its performance across the range. In this case of design verify you can usually have a small number of devices tested across a full range of conditions. I typically would recommend 3 devices just to be safe. The ‘number of conditions tested on each device’ is then the real sample size.
 
Thread starter Similar threads Forum Replies Date
N Help a newbie to develop a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
S Need help with analysing a survey on minitab Using Minitab Software 1
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
I Help: QFD House of Quality Quality Tools, Improvement and Analysis 1
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
M Thanks for the help Coffee Break and Water Cooler Discussions 0
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Burn out - Tips to help combat QC burnout Career and Occupation Discussions 9
Emran.mi Measurement system analysis - Can you help me about implementation MSA for CMM device Manufacturing and Related Processes 2
S New to FAIR, need help in filling it out AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
M Reliability Testing - Weibull Analysis Help Reliability Analysis - Predictions, Testing and Standards 4
L Help me to decide which test to use - If each proportion belongs to the same population Using Minitab Software 7
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1
R Pls help --- Need expert advice on Video Measurement Measurement Uncertainty (MU) 0
B Will you please help me with my academic project? Repair & calibration service for test equipment ISO 17025 related Discussions 0
B [Help] Customer Engagement Survey for MBA Project - due Apr19 Manufacturing and Related Processes 0
B Help with Customer Engagement Survey for MBA Project - due Apr19 General Measurement Device and Calibration Topics 0
Q ISO 3310 Clarification Help - Aperture sizes for sieves used for particle sorting Other ISO and International Standards and European Regulations 2
Ajit Basrur Need help to understand HIPAA requirements ISO 13485:2016 - Medical Device Quality Management Systems 17
JoshuaFroud FDA Form MDSAP AU F0029.1.004 - Help with Completion US Food and Drug Administration (FDA) 0
supadrai Aviation MRO Project facility coming to U-Tapao airport in Thailand - Help Career and Occupation Discussions 2
E Small one man shop with QMS (shoptech e2) | AS9100 cert help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 46
L Please help me with the process of getting ISO 9001 certified Quality Management System (QMS) Manuals 15

Similar threads

Top Bottom