SBS - The best value in QMS software

Question regarding ECO process, specifically for Life Science products and defining form fit and function

D

duff999

Involved In Discussions
#1
#1
I am creating the ECO process for a Life Science products, and I am stumbling with the form fit or function definition and how it would apply to these products. Typically for medical device products I can define this pretty easy but struggling a bit on this one. Any help would be appreciated.
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
William55401

William55401

Involved In Discussions
#2
#2
Instead of thinking about form, fit, and function, think about it from a Design Change perspective. Are DHF documents impacted? Inputs, Outputs, V& V, RMF? Ensuring DHF is maintained when Design is changed will better serve you IMHO. Getting your org to align on what is a design change will be helpful in the long term to ensure released products are maintained in a compliant state.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Question regarding "storage and distribution" ISO 13485:2016 - Medical Device Quality Management Systems 1
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
C Question regarding Quality Manual Content and Specificity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
optomist1 Generic question regarding Two Way ANOVA Results Statistical Analysis Tools, Techniques and SPC 8
apestate Question on wording in DOD RFQ regarding ISO 9000 Various Other Specifications, Standards, and related Requirements 7
N ASME B89.1.13 question regarding Resolution and Maximum Permissible Error General Measurement Device and Calibration Topics 3
B Question regarding Mandatory Procedures and Manual AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
P Question in auditing regarding CAR (Corrective Action) Logs Internal Auditing 7
S Supplier Development Process failed - Question regarding sub-suppiler audits IATF 16949 - Automotive Quality Systems Standard 4
Q Question regarding O-ring application for water proofing a device Design and Development of Products and Processes 2
J Question regarding Device Master Records & Specification Developers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
J Question regarding supplier approvals ISO 13485:2016 - Medical Device Quality Management Systems 12
J Cancellation of Specifications - Question regarding cancelled specifications Various Other Specifications, Standards, and related Requirements 3
ScottK ASME B&PVC Section VIII Div 1 question regarding "Seal" Various Other Specifications, Standards, and related Requirements 0
K Auditor's Question Regarding TS16949 Clause 7.5.2 - How vague can an auditor be IATF 16949 - Automotive Quality Systems Standard 18
S Question regarding document control - Control EVERY version of the same graphic? Document Control Systems, Procedures, Forms and Templates 5
A Question regarding TS16949 auditor rules 3.3 - Different auditors IATF 16949 - Automotive Quality Systems Standard 4
C Question Regarding MSA (Measurement Systems Analysis) - Pass / Fail Criteria tests Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
E Question Regarding OHSAS 18001 Occupational Health & Safety Management Standards 3
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
A Quality engineering positions in US - question Job Openings, Consulting and Employment Opportunities 1
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
M Question for Auditors - "Off the Record" Conversation? General Auditing Discussions 14
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A Question on Authorized Representative in Malaysia Other Medical Device Regulations World-Wide 3
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Question for: Cg & Cgk calculation General Measurement Device and Calibration Topics 3
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 6
hogheavenfarm GDT Flatness measurement question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 11
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Another DFAR question 252.225-7009 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
F Conflict Mineral Smelter Question RoHS, REACH, ELV, IMDS and Restricted Substances 8
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
C MDR - Question around software accesories EU Medical Device Regulations 2
K My question is, what/when is a nonconformity? Therefore what requires an NCR? Nonconformance and Corrective Action 9
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3

Similar threads

Top Bottom