Risk Classification For Supplier - Clinical Research Organisation (CRO)

#1
I am in process of approving a Clinical Research Organisation (CRO) to support our clinical investigations. Are there guidelines for supplier risk classification that i can use to determine risk level of the CRO?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#4
You should follow your own SOP dealing with supplier assessment, selection and qualification. If it's silent about the topic consult ISO 13485:2016.
 
Thread starter Similar threads Forum Replies Date
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
DuncanGibbons Classification of aerospace parts depending on their risk and criticality etc. Federal Aviation Administration (FAA) Standards and Requirements 3
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
T European MDD Classification of Medical Devices (Risk Class) EU Medical Device Regulations 15
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
Q Example of the Risk Template Document Control Systems, Procedures, Forms and Templates 1
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D Importing a general wellness low risk product Other US Medical Device Regulations 3
C Quantifying risk in choosing the number of parts, operators and replicates in a GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R AQL, Consumer Risk and MA Statistical Analysis Tools, Techniques and SPC 2
M Risk managment report of Surgical Mask Example ISO 14971 - Medical Device Risk Management 14
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
K Identification of hazards and Risk file IEC 62366 - Medical Device Usability Engineering 7
S Risk based internal auditing Internal Auditing 6
Robert Stanley I'm @ RISK of not showing my RISKS! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 1
adir88 Information of safety can reduce risk now? ISO 14971 - Medical Device Risk Management 12
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 5
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 14
Tagin Is SARS-CoV-2/COVID-19 on your risk register? Misc. Quality Assurance and Business Systems Related Topics 11
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 3
D Performance specification as a Risk Control Measure, EN 14971 ISO 14971 - Medical Device Risk Management 7
Sidney Vianna IAQG SCMH explains "positive risk"..........but does it? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
MrTetris Unacceptable risk and information for safety ISO 14971 - Medical Device Risk Management 16
M IATF 16949 (6.1.1 - Planning and Risk Analysis for a remote site) Process Maps, Process Mapping and Turtle Diagrams 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
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M An example of risk analysis of class I MD ISO 14971 - Medical Device Risk Management 36
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
M Risk and Corrective actions - Currently no FMEA's - Car systems Risk Management Principles and Generic Guidelines 8
P Risk acceptability alignment between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 6
U When do we identify Residual Risk? Risk Management Principles and Generic Guidelines 11
R Risk Management in the Medical Device Industry ISO 14971 - Medical Device Risk Management 4
U Changes to Internal Processes and Risk Evaluation - Mitigations Risk Management Principles and Generic Guidelines 10
J Can a risk be an opportunity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Similar threads


















































Top Bottom