SBS - The best value in QMS software

FDA Microscope IQ (Installation Qualification) Requirements

J

jdm2008

#1
#1
Do you IQ microscopes at your facility? Does the FDA expect microscopes that do not take a measurement to be IQed?
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
jdm2008 said:
Do you IQ microscopes at your facility? Does the FDA expect microscopes that do not take a measurement to be IQed?
Click to expand...
Hi,

IQ is part of process validation. The microscope needs an IQ only if it takes part in a process that is being validated.

Measurement is a separate topic and comes under MSA (GR&R etc.) and calibration.

Cheers,
Ronen.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 4
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 12
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
P Choice of FDA reviewer US Food and Drug Administration (FDA) 6
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Watchcat FDA Webinar Series - N95 Respirators Other US Medical Device Regulations 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
D FDA De Novo Cover Letter - What is expected US Food and Drug Administration (FDA) 3
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom