Procedure for Device End of Life/Obsolescence

funkgirl

Involved In Discussions
#1
Does anyone have an SOP to EOL a device? I've Googled the topic, but can only find stuff related to marketing but not from an internal perspective. I've got regulatory stuff covered (since that's what I do), but am looking for considerations from an internal perspective (QMS and non-QMS related).

Any insights are greatly appreciated. Thanks!

Tina
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Try to make a list of all stakeholders, list each one's needs related to EOL, then address each as you see fit.
 

funkgirl

Involved In Discussions
#3
Have tried that, but as the majority of our staff have zero prior medical device experience, they have no idea what they need.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Have tried that, but as the majority of our staff have zero prior medical device experience, they have no idea what they need.
1. Stakeholders are not necessarily within your staff.
2. You can try to speculate, then try to verify outside the org (even here, maybe).
 
Thread starter Similar threads Forum Replies Date
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
A MAH license transfer (medical device registrant) procedure in Indonesia Other US Medical Device Regulations 0
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
A Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability? Other US Medical Device Regulations 10
alonFAI Please share a medical device company NCMR procedure Other Medical Device Related Standards 5
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Japanese medical device recall requirements & procedure for foreign manufacturers Japan Medical Device Regulations 4
P What is expected in a Medical Device Commercial Release Procedure Design and Development of Products and Processes 3
S What is the procedure to reclassify a Medical Device in Canada? Canada Medical Device Regulations 3
K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Document Control Systems, Procedures, Forms and Templates 11
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1
somashekar Electronic data Back-up procedure, for Medical device QMS and regulatory purpose. ISO 13485:2016 - Medical Device Quality Management Systems 4
S Medical Device Reporting SOP (Standard operating procedure) example Other Medical Device and Orthopedic Related Topics 1
J Quality Procedure to handle some standard Medical Device Processes Document Control Systems, Procedures, Forms and Templates 1
J Medical Device Procedure Pack IFU's (Instructions for Use) ISO 13485:2016 - Medical Device Quality Management Systems 5
F OEM has no procedure for calibrating their device General Measurement Device and Calibration Topics 4
T Medical Device Reporting Procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
E Does MDD (Medical Device Directive) Require a CAPA Procedure? Document Control Systems, Procedures, Forms and Templates 3
J Medical Device Recall Procedure example wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
C Storage Managment (Stock Control and Storage) procedure for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
K Medical Device Software Development Procedure IEC 62304 - Medical Device Software Life Cycle Processes 20
M Non-Conformance Procedure FlowChart for a Medical Device company Document Control Systems, Procedures, Forms and Templates 3
A Procedure for Completing Medical Device Project Plans ISO 13485:2016 - Medical Device Quality Management Systems 5
C Medical Device Reporting procedure - Correction and Removal (21 CFR 806) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Medical Device Advisory Notice Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
M FDA Audit Procedure - SOP - Small Medical Device Company Document Control Systems, Procedures, Forms and Templates 19
N Suggestions for FDA compliant QA procedure for invitrodiagnostic device? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Combinational Device - Fluorescence Dye - Fluorescence Intraoperative Procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
Ajit Basrur Control of Medical Device Labels and Labelling Activities - Looking for a procedure Document Control Systems, Procedures, Forms and Templates 15
D Dock-To-Stock procedure - Medical Device Company Document Control Systems, Procedures, Forms and Templates 1
A Mechanical Design Procedure - Infusion pump incorporating software - Medical Device Design and Development of Products and Processes 1
S NCR under MDD - No documented procedure for class I device registration mechanism ISO 13485:2016 - Medical Device Quality Management Systems 2
B Procedure packs with non-medical devices EU Medical Device Regulations 1
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
A SPC procedure / flow chart Statistical Analysis Tools, Techniques and SPC 2
J Action Not defined in procedure - NC - Incoming inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
U Procedure pack components EU Medical Device Regulations 3
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
A IVD in MDR procedure pack EU Medical Device Regulations 2
G RoHS Procedure REACH and RoHS Conversations 2
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom