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Home CER – Role of Consultants and Clients

Role of Consultants & Clients

in the development of Clinical Evaluation Report for Medical Device

DOCUMENTATION

  SCOPE OF WORK (I3CGlobal) 

 SCOPE OF WORK (Client)

STAGE 0

0.1    Clinical Evaluation Procedure 

  • Development of Quality System Procedure(s) (QSP), SOPs and templates as per CLIENT MDQMS /GMP relevant for MDR documentation related to Clinical Evaluation
  • Clinical Evaluation Planning

 

  • DOI and CV template
 

  • Requires input for current stage of Clinical Development of the device
  • Requires documentation numbering according to the control of documents of CLIENT QMS system
0.2    SOP for Clinical Evaluation Plan
0.3   Clinical Evaluation Plan
0.4    Draft of Declaration of Interest (DOI)
0.5    CV of the Evaluator

 

 

STAGE 1

1.1    SOP for Identification of Pertinent Data 

  • Formats SOPs and templates as per CLIENT MDQMS /GMP
  • Identifies data that can be retrieved from CLIENT and adds data based on that to the template

 

  • Plans the literature search based on the keywords as per the PICO
  • Performs a systematic and comprehensive literature search from scientific databases based on research questions to meet the requirements of Annex I, MDR [GSPR]

 

  • Prepares the literature search report for meeting the requirement of safety and performance of the device
 

 

 

  • Information of pre-clinical studies and non-clinical studies

 

  • Information of any clinical studies such Clinical investigations as ISO 14155 or Post-market studies on the device as per I3C team request
1.2    Data Retrieved from the Manufacturer
1.3   SOP for Literature Search and Review
1.4   Literature Search and Review Plan
1.5   Literature Search and Review Report

STAGE 2

2.1    SOP for Demonstration of Equivalence
  • Formats SOPs and templates as per CLIENT MDQMS /GMP
  • Performs demonstration of equivalence (if a contract has been signed between your company and the manufacturer of equivalent device)
  • Informs about similar device details obtained from literatures (if any)
  • Appraises the clinical data collected from the CLIENT as well as that from the literature search
  • Contract between CLIENT and equivalent device manufacturer (if applicable)

 

  • Identification of equivalent device and provide the details for demonstration of equivalence (if claiming the equivalency)
2.2    Demonstration of Equivalent Devices
2.3    SOP for Appraisal of Clinical Data
2.4    Clinical Data Appraisal Plan
2.5    Appraisal of Pertinent Data

STAGE 3

3.1    SOP for Analysis of the Clinical Data 

  • Formats SOPs and templates as per CLIENT MDQMS /GMP
  • Performs qualitative analysis of the clinical data obtained from the literature as well as data retrieved from CLIENT
 

 

 

 

3.2    Analysis of the Clinical Data

STAGE 4

4.1   SOP for Development of CER 

  • Formats QSP, SOPs and templates as per CLIENT MDQMS/GMP
  • Creates the CER based on the summary of inputs from clinical data from CLIENT and the literatures from stage 1 meeting the GSPR
  • Reviews, guides and makes necessary modification on CLIENT RMF
  • PSUR and PMCF plan and reports
  • For PMS – Data collection and analysis based on the reactive and proactive sources selected by CLIENT, Preparation of PMS report with CLIENT’s support
  • For PMCF – Supports in selection of the model or variant for the study, Prepares PMCF Evaluation Report
  • For initial PSUR- Benefit-risk determination and conclusion
  • Suggests changes in the IFU based on the inputs from the CER, RMF, PSUR, PMS/PMCF
  • Provide documents such as previously submitted CER, RMFs, PMS/PMCF and the IFU or the user guide/manual

 

  • For PMS – PMS planning, Customer feedback reports of the specified time period, Complaint records, CAPA reports, Information of Sales history, Sales volume or any other supportive evidences based on the sources selected for PMS
  • For PMCF study – PMCF planning, selection of PMCF study based on I3C inputs, selection of study centers, appointment of Clinical investigator(s), Analysis and study conclusion
  • For initial PSUR- Acceptability of benefit-risk profile, Information of usage frequency of the device
  • Approvals in all the documents prepared by I3C

 

4.2   Clinical Evaluation Report with below supporting evidences
4.2(a) Risk Analysis procedure + Risk Management File
4.2(b) Post Market Surveillance (PMS) procedure + Records Templets + PMS Plan + PMS records (Client must organize as per our guidance)
4.2(c) Post Market Clinical Follow-up (PMCF) procedure + Records Templets +
PMCF records (Client must organize as per our guidance)
4.2(d) Periodic Safety Update Report (PSUR)
4.2(e) IFU

 

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I3C SCOPE (General)

CLIENT SCOPE (General)

01

 

  • Maintains data security and privacy for all documents generated on behalf of CLIENT also for the documents provided by CLIENT
  • Maintains safety & security of the files in cloud DROPBOX
  • Assures Virus protection
  • Weekly Project status update on Fridays.
  • Weekly email communication status update on Fridays
  • Maintain on-time delivery of documents as per CLIENT instruction and initial agreement.
  • At least one core technical person must interact with I3C team for the first TWO months of project initiation.
  • CLIENT technical team should have DROPBOX access
  • Access to Skype, WhatsApp, Email, Mobile for communication.
  • CLIENT team must provide product scientific and technical details whenever asked by I3C team
  • CLIENT should coordinate with I3C team for the timely completion
  • CLIENT should review all documents prepared by I3C team

02

  • Language of Communication – English
  • Geographical Location of Technical Consultants – India
  • Minimum Assurance on team qualification – Postgraduates and Graduates in Microbiology, Pharmacy, Biomedical.
  • Minimum promise of manpower allocation is Maximum 4 Nos.
  • Travelling to client location by our consultants on request and planned schedule only in case of necessity. We charge   $ 300/day + Accommodation and traveling cost from Bangalore, Dusseldorf or Chicago for a maximum of 2 days.