Aging rig in medical device industry - To qualify or not

#1
Hi,
I need some help in my thinking and to do some bench marking.

I'm working with medical device and in R&D we do component verification.
Part of component verification is to do stress tests / aging tests where the components are exposed to cold/heat/chemicals/pressure etc using a purpose built test rig. The rig is built upon calibrated sensors and a control software.

If the test rig would gather any measurements I gladly classify the rig as GxP and thus be subject to qualification (validation) according to our procedures.
However, the rig does not take any measurements or gather any results. It purpose is only to expose the components during a predetermined time.


  1. If you have similar equipment - do you qualify (IQ/OQ) or anything else?
  2. What did you base your decision on for how to treat the rig?
Thank you!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
How can you be sure that the rig did what you intended it to do? I suppose no one sits there to supervise it while it works.
 

yodon

Staff member
Super Moderator
#4
I'll "third" Ronen's response and agree qualification is needed. You're making quality decisions based on the use of the equipment so you need to have confidence that the equipment is doing what's intended.

Further, since it has control software, the software itself should be validated!
 
#5
Thank you all!

I actually think I can draw a parallel to the use of a climate chamber, which I would always qualify.
The chamber itself do not measure anything on the component, but I want to be sure it works as expected.

(Comment - the people voting for non-qualification will claim that it is not GxP and it can be controlled by calibrating sensors before and after test run to reassure it has performed as expected)

Cheers!
 
Thread starter Similar threads Forum Replies Date
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 1
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
shrutisancheti Predicate device accelerated aging - 1 year of shelf life is already over Other Medical Device Related Standards 1
A Accelerated aging and real time study EU Medical Device Regulations 2
M Real-time-aging Validation - ISO / ASTM Standard - Class 111 Orthopedic Implant Other Medical Device and Orthopedic Related Topics 1
Sam Lazzara Time Zero testing in med device aging studies Qualification and Validation (including 21 CFR Part 11) 3
shimonv Storage Conditions of 5-40 Celsius - Accelerated and real time aging - Dilemma EU Medical Device Regulations 3
W Shelf life and accelerated aging ISO 13485:2016 - Medical Device Quality Management Systems 2
N Accelerated Aging Testing Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
U Accelerated Aging for Shelf Life - Beginning Point Difference CE Marking (Conformité Européene) / CB Scheme 2
N Accelerated Aging Test for Disposable Protective Garment for Incontinence Other US Medical Device Regulations 1
S Medical Device Aging & Safety Questions by FDA Other US Medical Device Regulations 6
B Test Procedure or Standard for Accelerated Aging for AIMD Various Other Specifications, Standards, and related Requirements 2
E Aging/Shelf-Life Testing Responsibility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
P Regression Analysis for Aging Study in Minitab Statistical Analysis Tools, Techniques and SPC 10
Marc Aging in Mice Reversed - Immortality, anyone? World News 2
S Audit Summary Report - Nonconformance Aging Analysis Nonconformance and Corrective Action 10
A Medical Device (Gloves) Stability (Aging) testing and Shelf Life Other Medical Device and Orthopedic Related Topics 15
A Format of Stent Stability Testing (Accelerated and Long Term Aging) Other Medical Device and Orthopedic Related Topics 8
C Thermal Accelerated Aging Test(s) for Epoxy Reliability Analysis - Predictions, Testing and Standards 6
P Can I submit a 510(k) without aging data? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Aging Buckets for Metrics - Redefining a full set of metrics Six Sigma 3
Stijloor Aging Gracefully Funny Stuff - Jokes and Humour 1
S Validation of Sterilization Expiry Date - Accelerated Aging, etc ISO 13485:2016 - Medical Device Quality Management Systems 6
B Maintenance FMEA's - Aging Plant Equipment FMEA and Control Plans 6
E Uncertainty of Mean - Test rig that measures water temperatures Measurement Uncertainty (MU) 3
S RIG testing and BCR list - Heard of these acronyms? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
B MSA Study on Test Rig Constraints - Destructive, Long Duration Tests Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
Ajit Basrur Random Insult Generator (RIG) Coffee Break and Water Cooler Discussions 2
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 3
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
M Indian Medical Device Rules --Manufacturing and Whole sale Lic. Required ? Other Medical Device Regulations World-Wide 0
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 0
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Medical device Mode Of Action CE Marking (Conformité Européene) / CB Scheme 2
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom