Literature used in the clinical evaluation

W3r0nika

Starting to get Involved
#1
Hello,
I have a question about the literature used in the clinical evaluation.
Does it have to be paid articles, or do several must be paid?
Is a paid base with access to articles, or for each article I have to pay?

Regards and thanks
 
Elsmar Forum Sponsor

Rincewind

Involved In Discussions
#2
The quality of a paper or article used for your clinical evaluation does not depend on whether it cost money.
It is true though that in most cases a lot of the articles you want to use probably come from paid sources, such as research journals or maybe scientific books.
You will need to archive all papers you used, so you will have to buy all who are not free.

In your clinical evaluation procedure you've defined criteria you use for the appraisal of the clinical data you collect. MEDDEV 2.7/1 rev 3 and rev 4 have relatively good annexes about that, whether you paid for the access to an article is not one of them.
 

W3r0nika

Starting to get Involved
#3
In clinical evaluation I have articles mainly from pubmed but none is paid, can the auditor attach to it? Is there a record somewhere that they must be paid?
 

Rincewind

Involved In Discussions
#4
If the articles you found on pubmed were freely available or published in Open Source Journals you should be fine, to my knowledge no requirement for paid articles exist, frankly I think such a requirement would be stupid especially in the light of rising popularity of Open Source Journals.
 

Watchcat

Trusted Information Resource
#5
No need to wait around for open source journals to rise, just follow long-standing practice with journal articles. As long as you don't re-publish the article or claim authorship, you're fine. Many of the same articles are available for free from university/med school libraries, but access is typically limited and often with a lot of hoops to jump through, starting with finding a space in university/med school parking.

However, if you can't find a way to get it for free, I don't think "we can't afford it" is a justification for excluding an article from your evaluation.
 
Thread starter Similar threads Forum Replies Date
SK13485 Can a literature alone be used for the purpose of Clinical Evaluation of a device? EU Medical Device Regulations 6
M MDR Literature search timeline EU Medical Device Regulations 13
A Literature review/HACCP validation of metal detection Food Safety - ISO 22000, HACCP (21 CFR 120) 0
M Informational Grey literature and medical devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA paper – Epidemiological Evidence on the Adverse Health Effects Reports in Relation to Mercury from Dental Amalgam: Systematic Literature Review Medical Device and FDA Regulations and Standards News 0
Watchcat CERs Literature Databases - Searching for data to evaluate EU Medical Device Regulations 16
J Literature Review (marketing etc) ISO 13485:2016 - Medical Device Quality Management Systems 1
J CER - Literature search strategy and PMV data Timeline - MEDDEV 2.7.1/ Rev 4 CE Marking (Conformité Européene) / CB Scheme 2
H CER - Considering similar device/other medical devices for as relevant literature CE Marking (Conformité Européene) / CB Scheme 4
M Clinical Evaluation - MEDDEV 2.7/1 rev4 - Literature route Other Medical Device Related Standards 2
S Literature Search - Notified Body Had Questions About our Rationale CE Marking (Conformité Européene) / CB Scheme 1
K Non-Normal Data Analysis Literature, Websites, Books for Learning Quality Tools, Improvement and Analysis 2
R IQ/OQ/PQ Literature - Learning and implementing IQ/OQ/PQ procedures at my facility Design and Development of Products and Processes 3
A Finding Literature References for Clinical Evaluations per Annex X of MDD 93/42/EEU EU Medical Device Regulations 2
A Quitting ISO 9001:2000 - Necessary Changes to product literature, logos, etc. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Q Books / Literature: Risk Management for Medical Device Software recommendations Other Medical Device and Orthopedic Related Topics 4
S Clinical Evaluation using the Literature Method - Example or information wanted EU Medical Device Regulations 26
N Proving a Medical Device is equivalent to another device from Literature Review EU Medical Device Regulations 4
D FDA CGMP's Training Material - Slides, literature, handouts, etc. Training - Internal, External, Online and Distance Learning 1
S How do you let customers know you are certified on your literature? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R ISO 10993 - Required Testing - Can I follow the literature route? ISO 13485:2016 - Medical Device Quality Management Systems 3
Marc Liberating Scholarly Literature with E-Prints and Open Access Journals Book, Video, Blog and Web Site Reviews and Recommendations 0
L How many registrars require the use of their name in company literature Registrars and Notified Bodies 11
L Clinical Data Report - Literature Route - MEDDEV guidance (MEDDEV 2.7.1) EU Medical Device Regulations 28
I Seeking: References for online literature about ISO/TS Implementation Book, Video, Blog and Web Site Reviews and Recommendations 1
C What literature is available on Preventive Action? Book, Video, Blog and Web Site Reviews and Recommendations 7
D Control of Point of Sale Literature Document Control Systems, Procedures, Forms and Templates 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
D Can PFMEA be used in disposition of NC material? ISO 14971 - Medical Device Risk Management 4
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
John Broomfield Informational Terms used in quality management [Deleted] Misc. Quality Assurance and Business Systems Related Topics 6
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6
R Foam mattresses used in hospitals - compliance with MDR requirements? EU Medical Device Regulations 6
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
I Custom software services to be used by medical software ISO 13485:2016 - Medical Device Quality Management Systems 1
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
R PMCF - centers/countries used CE Marking (Conformité Européene) / CB Scheme 0
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
G Can calibrated device values be used instead of manufacturers spec? General Measurement Device and Calibration Topics 2
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
D What is the best software used for the pharma compliance management? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
I Recommendation about h and k values when CUSUM charts are used Statistical Analysis Tools, Techniques and SPC 4
R Please share your method used for PEMS Validation IEC 62304 - Medical Device Software Life Cycle Processes 5
D Determining Calibration Frequency schedule for items used in production Manufacturing and Related Processes 2
Similar threads


















































Top Bottom