SBS - The best value in QMS software

Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão

Marcelo

Inactive Registered Visitor
#1
ISO TC 210 JWG 1 met last week in Stockholm to discuss the last steps of the revision of ISO 14971 and ISO 24971. The group finalized the discussion on the comments of ISO TR 24971 (with only a couple of comments awaiting discussion in the next weeks) and it is expected to circulate ISO TR 24971 together or a little after the circulation of the FDIS of ISO 14971.

The plan is to finish the work at the London ISO TC 210 meeting in October.

ISO 14971 is expected to be published in November, and ISO TR 24971, some two months later.

O ISO TC 210 JWG 1 reuniu-se na semana passada em Estocolmo para discutir os últimos passos da revisão da ISO 14971 e ISO 24971. O grupo finalizou a discussão sobre os comentários da ISO TR 24971 (com apenas alguns comentários aguardando discussão nas próximas semanas ) e espera-se que circule o ISO TR 24971 em conjunto ou um pouco depois da circulação do FDIS da ISO 14971.

O plano é concluir o trabalho na reunião ISO ISO 210 da London em outubro.

Espera-se que a ISO 14971 seja publicada em novembro e a ISO TR 24971, cerca de dois meses depois.

Posted at Marcelo's Medicaldevice.expert website...

You may comment and discuss in this discussion thread.
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
From Reducing the risks of medical devices: international guidance just updated

ISO 14971, Medical devices – Application of risk management to medical devices, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products.
Primarily intended for medical device manufacturers, the ISO standard promotes the safety of devices and equipment used for medical purposes. It covers the risks of injury related to the health of patients, the operator and other persons, as well as potential damage to property, equipment and the environment. The standard was updated to better align with changes in medical device regulations around the world.
The ISO 14971 revision was aimed at clarifying the standard’s technical requirements by including more detailed information on the steps manufacturers must take to meet those requirements. It also includes new and updated terminology to reflect the current market needs. The guidance has been moved to the standard’s accompanying technical report ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, which was revised in parallel.
 
Thread starter Similar threads Forum Replies Date
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 6
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 8
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
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 5
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
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
B Our NB says that IEC 62304 is an ISO 14971 Requirement ISO 14971 - Medical Device Risk Management 1
B Clarification on interpretation of some EN ISO 14971:2012 & IEC 62304:2006 req's ISO 14971 - Medical Device Risk Management 46
H ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device) ISO 14971 - Medical Device Risk Management 1
M ISO 14971 and ISO TR 24971 revision ISO 14971 - Medical Device Risk Management 32
F ISO 14971:2012 and the FDA ISO 14971 - Medical Device Risk Management 5

Similar threads

Top Bottom