New ISO 14971:2019 Harm: unreasonable psychological stress, and cybersecurity

Elsmar Forum Sponsor
#12
As some of the comments above suggested, building a parallel cybersecurity path for the product, with integration into existing QMS processes is one that seems to be working with many manufacturers. Specifically for risk assessment, all gaps identified in the threat model, security testing and missing controls should be evaluated from a cybersecurity perspective. Many in the industry leverage the Common Vulnerability Scoring System (CVSS) to perform this assessment and risks that cross a certain scoring threshold are then pulled forward into the safety risk assessment. Mitre has also released a CVSS rubric for healthcare, to be used with medical devices.

This is what a high level process would look like:
  • Identify all gaps that could be risks
  • Perform a CVSS assessment
  • Determine the appropriate threshold for your organization and require those above that to have a safety risk assessment performed, those below do not. However, cybersecurity risks that do not impact patient safety may still require routine updates or patches
  • Perform a safety risk assessment - if possible utilize CVSS as the P values and keep the severity of impact as is, with the pre-defined hazards list
  • Determine next steps
  • Document all decisions, even if it is determined a risk is low and requires no remediation
The list above identifies the steps for performing this work on a product during design & development. You should also consider how to integrate cybersecurity with the QMS, such that it is part of the process and is repeatable.

Let me know if you have any additional questions on this, as I've been working specifically on device cybersecurity since the 2014 guidance came out (including successful PMA/510K approvals).

Thanks,
Colin Morgan
Managing Director

Apraciti, Medical Device Cybersecurity
[email protected]
 
Thread starter Similar threads Forum Replies Date
M ISO 14971:2019: Criteria for overall residual risk 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
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
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
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
M ISO 14971 Determination of Competent Persons ISO 14971 - Medical Device Risk Management 4
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
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
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
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 5
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
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
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