Archiving IVD Test Kit Raw Materials

S

SpartanBio

Involved In Discussions
Hi,

I am trying to determine how many samples of raw consumable materials I should archive per lot shipped to me. For example we make an IVD test kit that contains custom plastics these plastics are consumed when testing. I know I should be keeping samples for these but am unsure the best way to determine how many I should be keeping. Using the AQL tables seems like a lot of samples to be keeping. Any other thoughts out there?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Ron Rompen Document archiving software & hardware Document Control Systems, Procedures, Forms and Templates 0
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
E Accessory to a PACS (Picture Archiving and Communication System) system? EU Medical Device Regulations 4
T Medical Device PACS (Picture Archiving and Communication) - Class I or Class IIa? EU Medical Device Regulations 2
T Who makes archiving decisions in your organization? Document Control Systems, Procedures, Forms and Templates 10
C Archiving Systems to Track Documents - Pharmaceutical Company Document Control Systems, Procedures, Forms and Templates 5
R Data Analysis Software classified as MDSW IVD? EU Medical Device Regulations 3
Ed Panek Looking for help... FDA Pre Sub, IVD, Investigational level experience US Medical Device Regulations 0
T IVD Self-Test Notified Body Conformity Assessment Process EU Medical Device Regulations 0
T Clinical Study Design for IVD Self-Test (lay user) Products UK Medical Device Regulations 0
M Multiple DMRs for IVD Medical Device and FDA Regulations and Standards News 0
A CE IVD Mark - Emission certifications for unexpensive product CE Marking (Conformité Européene) / CB Scheme 1
M Class III IVD PMA Amendment to FDA Medical Device and FDA Regulations and Standards News 1
M IVD Device Design Change Medical Device and FDA Regulations and Standards News 2
BusyBee IVD relabeling UK Medical Device Regulations 2
R Selling same device as IVD and RUO US Medical Device Regulations 8
R Selling same device as IVD and RUO EU Medical Device Regulations 1
C South Korea - MFDS registration for a Chinese IVD factory Other Medical Device Regulations World-Wide 4
K IVD Usability IEC 62366 - Medical Device Usability Engineering 4
MaHoDie Regulatory compliance for IVD in india Other Medical Device Regulations World-Wide 2
S Registration of IVD in South Africa Other Medical Device Regulations World-Wide 2
T IVD Risk - destruction of patient samples - Harm to property? ISO 14971 - Medical Device Risk Management 5
T IVD Device Software - Risk Classification IEC 62304 - Medical Device Software Life Cycle Processes 16
R RUO and IVD Medical Device and FDA Regulations and Standards News 1
M UDI IVD - before submission? US Food and Drug Administration (FDA) 2
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
BusyBee IVD components supplied in bulk CE Marking (Conformité Européene) / CB Scheme 1
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
K Clinical Studies of MD and IVD in the US US Food and Drug Administration (FDA) 6
M Labeling IVD Class III Medical Device and FDA Regulations and Standards News 0
R IVD Label Change China Medical Device Regulations 1
R IVD Label Change Requirements Other Medical Device Regulations World-Wide 0
D IVD Accuracy and Precision Acceptance Criteria ISO 13485:2016 - Medical Device Quality Management Systems 1
K Brazil (INMETRO) for Medical Electrical and IVD Equipment? Other Medical Device Regulations World-Wide 4
E IVD devices helping labs meet CLIA/CAP QC requirements? Hospitals, Clinics & other Health Care Providers 0
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
S CE Marking components within IVD CE Marking (Conformité Européene) / CB Scheme 0
B IVD - GSPR checklist Other Medical Device Related Standards 0
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
T CE-IVD mark on packaging EU Medical Device Regulations 1
A Is computing Hardware part of the IVD CE Marking (Conformité Européene) / CB Scheme 3
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
B Looking for SSCP file of IVD devices EU Medical Device Regulations 7
B Research Use Only (RUO) IVD Medical Devices in China China Medical Device Regulations 2
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
Y Handbook recommended lightcycler for IVD Risk Management Principles and Generic Guidelines 1
S IVD Device History Record ISO 13485:2016 - Medical Device Quality Management Systems 5
J IVD sampling sizes for buyer Reliability Analysis - Predictions, Testing and Standards 0
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1

Similar threads

Top Bottom