SBS - The best value in QMS software

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
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
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

Similar threads

Top Bottom