Risk Management in an IVD, ISO 13485 certified company

L

LeoSobrinho

#1
I work for an IVD, ISO 13485 certified company. Our QMS is relatively new. We are trying and struggling with our Risk Management process.

Can you please advise on how to go about it? is a Risk Assessment only acceptable? Is it a must for the company to take into consideration the Severity of the risk?

Any guidance will be appreciated

Regards
 
Elsmar Forum Sponsor
S

SteveK

#2
Re: Risk Management

Have a look at my attachment - this may help (noting we are now on the 2012 version)

Steve

LINK TO POST WITH FILE REMOVED. I COULD NOT FIND IT TO FIX IT. SORRY...
 
Last edited by a moderator:
O

OleOvergaard

#3
Risk management is not something that can be applied as an add on to your QMS after development or manufacturing. Risk Management must be integrated in your QMS during both development, manufacturing and post market.

And risk assessment alone is certainly not enough. You must follow all the steps in ISO 14971, including risk management planning, assessment, evaluation, control, verification, reporting and post market surveillance. The extent of each of these steps depends of course of the classification of your IVD device. But they must all be performed and documented.

In EU, EN ISO 14971:2012 is harmonized against the IVD Directive, and thus, if you comply with 14971 your notified body has to presume compliance with the essential requirements of the IVD Directive. In USA, ISO 14971:2012 is a recognized consensus standard.

In other words: ISO 14971 is the way to go. You have to read it and understand it, including the informative appendices that gives examples and advice. In EU you should also pay attention to annex ZB.

If this seems too complex, you should either take some relevant training, hire some experienced consultants, or both.
 
Thread starter Similar threads Forum Replies Date
P Risk Management Files for IVD (Invitro Diagnostic Reagent) Kits ISO 14971 - Medical Device Risk Management 3
J HELP NEEDED ! Risk Management Exercise ISO 14971 - Medical Device Risk Management 12
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 10
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
H Risk Management Plan in agile process ISO 14971 - Medical Device Risk Management 14
U Supply risk management Manufacturing and Related Processes 4
T Biological Evaluation (10993) & Risk Management ISO 14971 - Medical Device Risk Management 9
D Cybersecurity and Risk Management: Loss of confidentiality IEC 62304 - Medical Device Software Life Cycle Processes 5
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
S Risk Management and other Files ISO 14971 - Medical Device Risk Management 8
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
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, NADCAP and Aerospace related Standards and Requirements 1
B ATP 5-19 "Risk Management" Misc. Quality Assurance and Business Systems Related Topics 2
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
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, NADCAP and Aerospace related Standards and Requirements 3

Similar threads

Top Bottom