SBS - The best value in QMS software

ISO 14155 - Electronic clinical data systems - Definition

Wolf.K

Involved In Discussions
#1
Hi,

I wonder if someone has an idea about the definition of ISO 14155' "electronic clinical data systems", chapter 6.8.3:

If I get print-outs of (anonymized) patient records and do some statistical calculation with the data for either a scientific publication or for the clinical evaluation of a device - is this data processing already what ISO 14155 calls an "electronic clinical data system"??

:confused: Wolf
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Good Clinical Practice (GCP) - ISO 14155 vs. ICH Other ISO and International Standards and European Regulations 10
Y My mission is to draft a procedure related to ISO 14155 - Good Clinical Investigation Practices Other Medical Device Related Standards 1
S ISO 14155 vs. BS EN ISO 14155 Other Medical Device Related Standards 2
P ISO 14155 GAP analysis Other Medical Device Related Standards 3
A ISO 14155:2011 - Registry Studies? Other Medical Device Related Standards 2
D What Standards can be used for Clinical Evaluation besides ISO 14155? ISO 13485:2016 - Medical Device Quality Management Systems 9
J ISO 14155:2011 - The meaning of the term "Should" EU Medical Device Regulations 8
Sidney Vianna ISO 14155:2011 - Clinical Investigation of Medical Devices for Human Subjects Other Medical Device Related Standards 0
T ISO 14155 Good Clinical Investigation Practices Compliance Checklist? EU Medical Device Regulations 1
bio_subbu ISO releases Standard on Good Clinical Practice (ISO 14155:2011) EU Medical Device Regulations 2
M Comparison of ISO 14155 to FDA Good Clinical Practice Other Medical Device Related Standards 8
T Application of ISO 14155 Clinical Trials Investigations EU Medical Device Regulations 5
F Clinical Audits to ISO 14155 - Performing audits of clinical affairs groups ISO 13485:2016 - Medical Device Quality Management Systems 4
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 14971 Determination of Competent Persons ISO 14971 - Medical Device Risk Management 4
R Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO Other Medical Device Related Standards 10
Q The scope of ISO 21534 Other Medical Device Related Standards 0
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 4
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
N Quality Compliance Officer - ISO 13485, London Job Openings, Consulting and Employment Opportunities 1
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
N ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
A Tips and Tricks to understand ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
K ISO 50001 Consultant wanted Paid Consulting, Training and Services 0
K Comparison wanted: ISO 15378:2018 vs. PS9000:2016 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
John C. Abnet ISO 45001:2018 (5.4 - Consultation and participation of workers) Occupational Health & Safety Management Standards 10
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
S ISO 15223-1:2020 Symbols Other Medical Device Related Standards 1
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
R ISO 10993-18 Medical Device and FDA Regulations and Standards News 1
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 4
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom