SBS - The Best Value in QMS software

Medical Device Stability Studies - Non-validated pilot production

Chef100

Starting to get Involved
#1
Hi!
I want to start a thread dealing with stability studies for M. Devices.
A common way is to do 3 lots but is it ok that the first lot comes from a non-validated pilot production as long as the items has been verified by measurement etc?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hi.

Typically stability studies are part of the pilot production validation, so yes - it's normal that the test units come from a yet unvalidated line. However, in such a setting the pilot line and the production process are expected to be qualified first and controlled within the limits that the line is supposed to be validated under. If successful, subsequent production will have to be controlled within the same, established limits.

The main point is that stability is (hopefully) established for a given production setting and a given set of controlled parameters settings (accounting for all the rest, which is noise, too), which is maintained for routine production later. Otherwise it's just anecdotal.
 
Thread starter Similar threads Forum Replies Date
J EU Medical Device Class I - Stability (Shelf Life) Test EU Medical Device Regulations 2
R Shipping Stability for Class III IVD (Non Sterile) Medical Device Other Medical Device Related Standards 7
L Medical Device Stability Testing Requirements EU Medical Device Regulations 1
A Medical Device (Gloves) Stability (Aging) testing and Shelf Life Other Medical Device and Orthopedic Related Topics 15
F Medical Device Stability Testing Other Medical Device and Orthopedic Related Topics 9
R Accelerated Stability Studies - Duration and Conditions - Class III Medical Device Other Medical Device and Orthopedic Related Topics 4
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 0
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 1
DanBOS Cloud Connected Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 0
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 1
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 3
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4
J Calling a medical device a medical device (when it might not be one..) UK Medical Device Regulations 29
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
N Medical device name in different countries EU Medical Device Regulations 4
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
Z Over The Air (OTA) updates for medical device Other US Medical Device Regulations 1
H Tukery Medical Device Regulstion Other Medical Device Regulations World-Wide 0
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 3
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 1
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom