SBS - The best value in QMS software

Incident Reporting MHRA (Medical & healthcare regulatory agency)

JoCam

JoCam

Trusted Information Resource
#1
#1
Hi All,

When compiling a final incident report detailing the investigation performed is it necessary to include names of individuals involved, or is it more appropriate to state job titles. I understand that under the data protection act patient details should not be disclosed, but what about persons spoken with during the investigation?

Jo
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
S

SteveK

#4
#4
The MHRA themselves will name contacts at the organisation who raised the incident report in the first place, so it will be a little academic.

Steve
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
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 Informational TGA – Medical device incident reporting (MDIR) guide Medical Device and FDA Regulations and Standards News 0
A Customer Complaint - Incident Reporting Hardcopy Signoff Customer Complaints 8
P Incident Reporting or a Complaint? IEC 27001 - Information Security Management Systems (ISMS) 9
M ISO 14001 Incident Reporting Procedure ISO 14001:2015 Specific Discussions 6
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
I How to handle pending FSN when incident happens? EU Medical Device Regulations 1
J Circadian Software Accident/Incident Analysis Business Continuity & Resiliency Planning (BCRP) 1
M Informational Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) Medical Device and FDA Regulations and Standards News 5
E Incident Report or Nonconformance Report for Equipment Failure? Quality Manager and Management Related Issues 5
L OHSAS 18001 Participation and Consultation - Incident investigation under 4.4.3.2 Occupational Health & Safety Management Standards 15
V Is non-conformance (incident) required for any observation in equipment qualification Nonconformance and Corrective Action 5
V How long can a development stage incident be open? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
S Incident Investigation Procedure for Critique Document Control Systems, Procedures, Forms and Templates 3
M What Indicator should we use to follow Incident Containment Nonconformance and Corrective Action 2
T Information System Security (infosec) Incident Form - Looking for samples IEC 27001 - Information Security Management Systems (ISMS) 4
V Should there be a incident/deviation for breakdown or missed calibration date? Nonconformance and Corrective Action 7
Richard Regalado ISO 27035:2011 Infosec Incident Management - Hot Off the Grill! IEC 27001 - Information Security Management Systems (ISMS) 0
K Incident Investigation vs. Root Cause Analysis ? What?s the difference? Customer Complaints 16
C Accident And Incident Investigation and Report procedure example wanted Miscellaneous Environmental Standards and EMS Related Discussions 6
Marc Stuxnet: The Curious Incident of the Second Certificate After Work and Weekend Discussion Topics 3
S Qantas Airbus incident - What really happened? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Is an accident an 'incident' or a 'nonconformance? Occupational Health & Safety Management Standards 29
P Transparency / Reciprocity - Medical device incident reported in the EU 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L Looking for Incident/Change/Problem Management Audit Checklist Document Control Systems, Procedures, Forms and Templates 3
A Looking for an FDA MDR/Incident Report Decision Tree ISO 13485:2016 - Medical Device Quality Management Systems 6
C Safety issue help - Request a Corrective Action (CA) for Safety Incident? Preventive Action and Continuous Improvement 9
R Vigilance reporting to the country of the EU authorised representative EU Medical Device Regulations 2
M Is it Necessary to Use Health Canada Form when Reporting? Canada Medical Device Regulations 1
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
L Adverse Event Reporting New Zealand Other Medical Device Regulations World-Wide 11
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
MDD_QNA How to deal with FDA after not reporting anything for several years Other US Medical Device Regulations 14
D Accident reporting categories Occupational Health & Safety Management Standards 1
T Trend Reporting under the EU MDR EU Medical Device Regulations 7
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF proposed document – IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Anne Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada – Mandatory reporting requirements for hospitals Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Statement on agency’s efforts to increase transparency in medical device reporting Medical Device and FDA Regulations and Standards News 0
A Japan's Requirements for Reporting Medical Device Adverse Events Other Medical Device Regulations World-Wide 2
T Why do most companies have Quality reporting to Engineering or Operations and not to CEO? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 45
M Informational TGA – Medical device annual reporting – Sponsor obligations Medical Device and FDA Regulations and Standards News 0
Marc European universities dismal at reporting results of clinical trials - 2019 Other Medical Device Regulations World-Wide 0
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom