SBS - The best value in QMS software

Looking for the FDA's Small Entity Compliance Guide

D

DavidHedfors

#1
#1
I?m looking for the Small Entity Compliance Guide, about 20 pages as I remember it. Not the 468 page Manual. Does anyone have a copy of that guide?

Thanks
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
A

ascherp

#2
#2
Please provide more information. For what FDA branch or type of product (food, medical device...), on what subject?
 
D

DavidHedfors

#3
#3
Sorry, I meant my post as a reply to this thread:

elsmar.com/Forums/showthread.php?p=557897#post557897

QSR for Medical Devices is the subject I?m interested in.
 
Last edited by a moderator:
A

ascherp

#4
#4
I printed some of the chapters before the FDA withdrew them from their website. Any specific chapter you need or all of them?
 
D

DavidHedfors

#5
#5
Right now I?m looking for Documentation guidelines, but from past experience, I need to consult this guide about once a month. If you can upload all of it, I would be grateful.

Thanks,
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2
A Looking for an FDA MDR/Incident Report Decision Tree ISO 13485:2016 - Medical Device Quality Management Systems 6
T Looking for an accredited FDA MED-DEV 3rd Party Auditor ISO 13485:2016 - Medical Device Quality Management Systems 4
J MSA - Is ISO 10012 the standard we are looking for to ensure the FDA will be happy Other ISO and International Standards and European Regulations 3
Q Looking for Best ISO 13485/FDA QSR Quality System Development Software Quality Assurance and Compliance Software Tools and Solutions 4
bryan willemot Looking for an Approved vendors list template Document Control Systems, Procedures, Forms and Templates 11
M Data Protection and Privacy Policy - looking for a template/example EU Medical Device Regulations 1
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
K Looking for guidance to write an SOP on Statistical Methodologies? Statistical Analysis Tools, Techniques and SPC 7
blackholequasar Looking into Nadcap for the first time AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 7
K Looking for a job as Quality Engineer Career and Occupation Discussions 2
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
M We are looking for a Contract Manufacturer US Food and Drug Administration (FDA) 2
mihzago Looking for an Australian/ NZ Sponsor Other Medical Device Regulations World-Wide 4
S New Foreign Exporter Looking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Looking to Impress - New Job - Advice, Thoughts, Comments Welcome Career and Occupation Discussions 23
J Looking for a training organization that can provide in house DFMEA training FMEA and Control Plans 4
A Looking for a third party to calibrate our measure equipment - South Carolina General Measurement Device and Calibration Topics 6
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
N Looking for Gamma sterilization facility in China ISO 13485:2016 - Medical Device Quality Management Systems 4
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 5
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
A New to QC, looking for resources Problem Solving, Root Cause Fault and Failure Analysis 3
bryan willemot Looking for a certified test report for aerospace parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
K I’m looking for a square probe for my linear height gauge Manufacturing and Related Processes 1
C Looking for China Good manufacturing practice China Medical Device Regulations 1
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
A We're currently looking for any studies performed on various PPE materials Qualification and Validation (including 21 CFR Part 11) 1
C Looking for APQP Training recommendations preferably in the aerospace industry APQP and PPAP 2
C Looking for simple Software Validation IQ templates. Qualification and Validation (including 21 CFR Part 11) 4
H Looking for Tips on finding an IATF consultant Consultants and Consulting 6
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
pashah Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6 IEC 62366 - Medical Device Usability Engineering 4
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
bryan willemot Looking for a good CoC to put with my certification sheets when we send parts Document Control Systems, Procedures, Forms and Templates 1
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0
K Looking for a good Six Sigma book Six Sigma 7
G Looking to move to an electronic QMS software Software Quality Assurance 11
C Looking for source of silicone contamination in ISO Class 8 Cleanroom Other Medical Device Related Standards 2
F Looking for a Japan MAH recommendation that is not too expensive Japan Medical Device Regulations 5
P Looking for Risk Assessment Template - Not necessarily Asset based IEC 27001 - Information Security Management Systems (ISMS) 1
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Looking for FMEA plastic injection molding FMEA and Control Plans 8
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6

Similar threads

Top Bottom