ISO 14971 Class II Medical Devices - Product Realization & Risk Management

Q

qremsg26

#1
Hi,

What will be the RA process flow for the medical devices Class IIa?

I am talking about the complete life cycle of the product, and not just the design.

Thanks,

:confused:
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
Re: ISO 14971:2009 Class II Medical Devices Process Flow

Can anyone help with this one? My Thanks in advance!
 
Q

qremsg26

#3
Re: ISO 14971:2009 Class II Medical Devices Process Flow

I need to do the risk analysis for the medical device, I would need the overview process input.

Thanks
 

Marc

Fully vaccinated are you?
Staff member
Admin
#5
Re: ISO 14971:2009 Class II Medical Devices Process Flow

Thanks, bio_subbu. I appreciate your help here.
 

Ajit Basrur

Staff member
Admin
#6
Hi,

What will be the RA process flow for the medical devices Class IIa?

I am talking about the complete life cycle of the product, and not just the design.

Thanks,

:confused:
Which market are you referring to ? If you are talking about Australian markets, the TGA website on Medical Devices is a good place to start.

Additionally on Risk Management, the TGA gives guidance HERE

.
 
Last edited:
Thread starter Similar threads Forum Replies Date
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 14971:2007 Risk Management - Class I A Sterile Medical Device ISO 14971 - Medical Device Risk Management 4
T Best Risk Analysis Approach (ISO 14971) - Class IIa Medical Devices ISO 14971 - Medical Device Risk Management 16
R ISO 14971 not harmonized ISO 14971 - Medical Device Risk Management 4
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
M ISO 14971 Determination of Competent Persons ISO 14971 - Medical Device Risk Management 4
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 11
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
M Gap analysis on ISO 14971:2019 with previous revision ISO 14971 - Medical Device Risk Management 12
Bill Hansen New ISO 14971:2019 Harm: unreasonable psychological stress, and cybersecurity ISO 14971 - Medical Device Risk Management 13
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
B ISO 14971 Applied to Software ISO 14971 - Medical Device Risk Management 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Ronen E Informational What's new in ISO 14971:2019 ISO 14971 - Medical Device Risk Management 2
T ISO 14971-2019 doubt - Evaluate if estimated risks are acceptable ISO 14971 - Medical Device Risk Management 9
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
P Risk acceptability alignment between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 6
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
R The difference b/w FMEA & Risk analysis as per iso 14971 ISO 14971 - Medical Device Risk Management 8
D Risk management according to ISO 14971 - When to document risk controls? ISO 14971 - Medical Device Risk Management 10
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
Q Information for safety EN ISO 14971:2012 - Customer Risk Reduction ISO 14971 - Medical Device Risk Management 6
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
A Our auditor requires us to attend a training on EN ISO 14971:2012 Other ISO and International Standards and European Regulations 3
S In a risk analysis, how can we tie mobile app security breach to ISO 14971? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F IMDRF opened a Consultation on Annex E & F and the link to ISO 14971 ISO 14971 - Medical Device Risk Management 4
M Updates to EN 62366 & ISO 14971? Other Medical Device Related Standards 3
D IEC 60601-1 and ISO 14971 Assessment IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
M Example ISO 14971 policy and risk criteria ISO 14971 - Medical Device Risk Management 0
P ISO 13485 and ISO 14971 - one mandates the other? ISO 13485:2016 - Medical Device Quality Management Systems 8
D Rationale for Risk Acceptability Matrix - ISO 14971 ISO 14971 - Medical Device Risk Management 9
H Task analysis and ISO 14971 ISO 14971 - Medical Device Risk Management 9
M ISO 14971 and Stand-Alone Diagnostic Software ISO 14971 - Medical Device Risk Management 4
dgrainger Benefit - What is the definition of Benefit in ISO 14971? ISO 14971 - Medical Device Risk Management 7
Y Training as a risk control for ISO 14971 ISO 14971 - Medical Device Risk Management 13
W Risk Benefit Analysis - ISO 14971:2012 Requirements ISO 14971 - Medical Device Risk Management 27
thisby_ ISO 14971 - ALARP and P2 - New ISO 14971 does not allow the concept of ALARP? ISO 14971 - Medical Device Risk Management 3
C What is the difference between "Overall Risk" and "Risk"? (ISO 14971) ISO 14971 - Medical Device Risk Management 10
B New EU Medical Device Regulation & Reconciling with EN ISO 14971 EU Medical Device Regulations 41
B IFU and deviation 7 in ISO 14971 Annex ZA ISO 14971 - Medical Device Risk Management 1
B Interpreting Deviations 5 & 6 in Annex ZA in ISO 14971:2012 ISO 14971 - Medical Device Risk Management 1

Similar threads

Top Bottom