Risk Management besides mandated FDA requirements

#1
What other considerations must be considered in order to have comprehensive approach to Risk Management besides the mandated requirements from the FDA?
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Are you asking about product risk management (ISO 14971 is the recognized consensus standard), process-based risk management (the 'risk based thinking approach called out in 13485), or something else? What "mandated requirements" are you referring to?
 
Thread starter Similar threads Forum Replies Date
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
B ATP 5-19 "Risk Management" Misc. Quality Assurance and Business Systems Related Topics 2
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
R Risk Management in the Medical Device Industry ISO 14971 - Medical Device Risk Management 4
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
Ronen E The unbearable insensitivity of risk management language Other Medical Device and Orthopedic Related Topics 1
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
M Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind EU Medical Device Regulations 10
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
R Linking the Processes of Continual Improvement, Change Management, Risk Management, Action Planning, etc? Preventive Action and Continuous Improvement 5
D Risk management according to ISO 14971 - When to document risk controls? ISO 14971 - Medical Device Risk Management 10
J Software for Techfiles and Risk management ISO 14971 - Medical Device Risk Management 1
M Informational ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 6
M Medical Device News ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 0
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
M Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Medical Device and FDA Regulations and Standards News 0
T Risk Management Report as per MDR Requirements EU Medical Device Regulations 4
S Medical Device Cybersecurity Risk Management File ISO 14971 - Medical Device Risk Management 2
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
Q Risk / benefit Analysis in Risk Management Report CE Marking (Conformité Européene) / CB Scheme 12
A How to view supplier APQP timeline and do risk management APQP and PPAP 4
O Medical Device EMC Risk Management CE Marking (Conformité Européene) / CB Scheme 4
S ISO 13485:2016 - How I can integrate a risk management approach in our SOPs ISO 13485:2016 - Medical Device Quality Management Systems 1
B Time necessary for all Risk Management activities ISO 14971 - Medical Device Risk Management 2
W Virtual Manufacturer and Risk Management ISO 14971 - Medical Device Risk Management 3
O CQE Handbook - Missing Section VII - Risk Management Misc. Quality Assurance and Business Systems Related Topics 1
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
J Differences between a Risk Management Plan vs. Production Part Approval Process AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
M Free Risk Management Webinar - Design for Quality - May 2017 Risk Management Principles and Generic Guidelines 1
J Will this fulfill the AS9100D Risk Management Requirement AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
A Including all Processes in Risk Management - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 8
F Risk Management vs. FMEA ISO 14971 - Medical Device Risk Management 11
T Using Risk Management in ISO 10993 - Medical Device Accessory 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Risk Management - Additional Process in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
J What ever happened to Medical Device Risk Management, anyway? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
M AAMI draft report - Postmarket Risk Management ISO 14971 - Medical Device Risk Management 2
L Risk Management in an IVD, ISO 13485 certified company ISO 14971 - Medical Device Risk Management 2
S Informational Risk Management Implementation for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 60
S Risk Management during Contract Review AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
M Risk Management File for Extra Oral RX Equipment ISO 14971 - Medical Device Risk Management 11
D Risk Management for Drug-Device Combinations ISO 14971 - Medical Device Risk Management 1
A AS 9100 - Risk Management Procedure and Flow Chart examples AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
R How to document the Risk Management on Rework activities ? ISO 14971 - Medical Device Risk Management 6
A Risk Management, complaint handling and CAPA system ISO 14971 - Medical Device Risk Management 5
Similar threads


















































Top Bottom