FDA Guidelines for implementing Continuous Improvement Process

new_to_this

Involved In Discussions
#1
Does anyone know where I can find FDA Guidelines for implementing Continuous Improvement Process for Medical Device industry? Your input would be greatly appreciated Thank you!!
 
Elsmar Forum Sponsor

jkuil

Quite Involved in Discussions
#2
I think you mean Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control in the Guidance for Industry Process Validation: General Principles and Practices of 2011.
It is not specific to the medical device industrie.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Maybe there's a misunderstanding here.
Continuous Improvement Process is not the same as Continuous Process Improvement.

I'm not aware of a specific FDA guidance for medical device manufacturers on Continuous Improvement Process. In my understanding continuous improvement can be achieved through a systematic and consistent application of a quality management system such as that prescribed by 21 CFR 820.

This document discusses Innovation and Continuous Improvement in Pharmaceutical Manufacturing.

Chapters IV & V of this document seem to be relevant too, though targeted at pharmaceuticals manufacturing.
 
Thread starter Similar threads Forum Replies Date
S FDA Registration food facility - We operate under CGMP guidelines US Food and Drug Administration (FDA) 0
K Rules or guidelines for quoting FDA announcements and such? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Marc New FDA Cybersecurity Guidelines for Medical Devices (Dec 2016) Other US Medical Device Regulations 0
Michael Malis New Saudi FDA Guidelines Other Medical Device Regulations World-Wide 1
D Process Validation Protocol (API) as per new FDA Guidelines Qualification and Validation (including 21 CFR Part 11) 18
S FDA guidelines for Calibration Lab needed US Food and Drug Administration (FDA) 2
B FDA acceptance of Guidelines vs Procedures ISO 13485:2016 - Medical Device Quality Management Systems 1
R Rubber Initial & Inspection Stamps - Valid or a violation of FDA quality guidelines? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
S Concession Procedure FDA Guidelines - medical devices. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Marc FDA has auditing guidelines posted on it's web pages for QSR ISO 13485:2016 - Medical Device Quality Management Systems 3
H Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
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 0
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
O Hospital-Developed, In-House Device - FDA Clearance? Other US Medical Device Regulations 19
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Looking for third party reviewers for FDA submissions US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom