PHASE

DESCRIPTION OF ACTIVITY

SCOPE OF I3CGLOBAL

SCOPE OF MANUFACTURER

PHASE 1

Legal Verification

Review & Approval

Confirmation of scope

Review & Approval

Confirmation of production site address, Manufacturing Registration Certificate/Company Registration Certificate, incorporation Certificate.

Review & Approval

Confirmation of critical outsourcing sites

Review & Approval

Quality Management Certificate i.e., ISO 9001:2015, ISO 13485:2016 etc.

Device Verification

Review & Approval

Device Models confirmation

Guidance, Review and Approval.

Generic name

Guidance, Review and Approval.

GMDN Code

Review & Approval

Trade Name / Brand Name

Review & Approval. Confirming device models

Device Variants confirmation
(Stock Keeping unit) SKU

Medical Device Rational

 

Guidance, Review and Approval.

Device Description

Review & Approval, identifying key functional component

Device Components

Review & Approval

Device Accessories

Guidance Review and Approval

Hardware / firmware / software

Guidance Review and Approval

Intended use

Guidance Review and Approval

Specification

Risk Classification

 

Software Level of Concern

 

Review & Approval

Indication

Review & Approval

Mechanism of Action

Review & Approval

Connections to the device

 

PHASE 2

Confirmation of MDR requirements and compliance issues

Identification of regulations

 

Harmonized Standards

 

Non-Harmonized standards

 

Device specific standards

 

Other applicable regulations if any

 

Declaration of Conformity

 

Documentation of additional declarations

 

 

PHASE 3

Design Controls
(Active, Non-Active Devices)
In line with ISO 13485

Procedure establishment for design and development.

 

Review & Comments

Development Plan

Review & Comments

Design & development inputs

Review & Comments

Design & development outputs

Review & Comments

Design Verification

Review & Comments

Design Validation

Review & Comments

Design Approvals

Review & Comments

Formulation / Drawings/ Specifications

Review & Comments

Bill of Material

Review & Comments

Design & development Review

 

PHASE 3

Design Controls
(Software)
In line with ISO 62304

Review & Comments

Development Plan

Review & Comments

Requirements Analysis

Review & Comments

Architectural Design

Review & Comments

Detailed Design

Review & Comments

Unit Implementation

Review & Comments

Unit Verification

Review & Comments

Integration & Integration Testing

Review & Comments

System Testing

Review & Comments

Software Configuration Management

Review & Comments

Software Risk Management Process

Review & Comments

The code and code reviews

Review & Comments

Software validation and release.

PHASE 4

Risk Analysis & Usability

Development of Procedures

Team support and suggestions

Conduct of risk Analysis

Risk Mitigation

Risk Benefit analysis

Risk Management File documentation

Review and approval

Usability engineering procedure establishment

Team support and suggestions

Review & Approval

Usability engineering test report

 

PHASE 5

Pre- Clinical

Biological Evaluation procedure establishment

 

Identification of biocompatibility compliance requirements.

 

Identification of electrical safety compliance requirements.

 

Review and Approval

Biocompatibility Plan

Review and Approval

Biocompatibility Test Reports

 

PHASE 6

Production controls

Guidance, review, and approval

Process Flow Chart

Guidance,

Critical Process identification

Review and approval

Critical Process validation protocol and reports

Review and approval

Sterilization Process Validation Protocol

Review and approval

Sterilization Process Validation Report

Guidance

Environmental Controls

Review and approval

Cleanroom Validation protocol and Records

Review and approval

Bioburden protocol and Records

 

PHASE 7

Device Labelling

Guidance, review, and approval

Primary / Secondary Labels including embossing’s submit as per guidance

Information For Use /
User manual

Guidance, review, and approval

Develop and submit IFU / User manual as per guidance

Device Storage

Review, and approval

Confirmation of storage time and condition

Lifetime / Shelf-Life

Guidance, review, and approval

Lifetime / Shelf-Life Protocol and Reports

Packaging Controls
(Active, Non-Active Devices)

Guidance, review, and approval

Method of Packing

Packing Validation and Reports

Transport Validation and Reports

 

PHASE 8

Quality Control

Review, and approval

Specification of Finished Device

Review, and approval

Specification of Critical Raw Materials / Components

Review, and approval

Quality Plan / Control Plan

Guidance, review, and approval

Certificate of Analysis (COA)

Guidance, review, and approval

Batch Release

Review, and approval

Performance Testing

Review, and approval

Electrical Safety Testing

PHASE 9

Clinical Evaluation

  • Development of Quality System Procedure, if not available with the manufacturer.
  • I3C may modify or suggest modifications to the manufacturer’s existing QSP.
  • Extend necessary support with document numbering based on MDQMS and control of documents
  • Guidance and drafting of templates
  • Assign clinical evaluator(s) as per the guidance and arrange the CV and DOI
  • Develop detailed Clinical Evaluation Plan
  • Develop the CEP template and fill it based on the evidence provided by the manufacturer such as IFU or User guide, RMF or previous CER.
  • Develop Literature search plan template and add information of literature search strategies.
  • Develop Appraisal plan template and add information - the criteria for appraisal of all the pertinent data.
  • Clarify doubts, when necessary.
  • Assign other responsible personnel involved in clinical evaluation and inform I3C
  • Review and approve CEP, Literature search plan and Appraisal plan
  • Develop Identification of Pertinent Data template
  • Guides manufacturer on pre-clinical and non-clinical studies.
  • Identifies data that can be retrieved from manufacturer and adds data based on that to the template
  • Extend necessary support for consultants with pre-clinical data in a systematic way.

 

  • Provide information of any clinical studies such as Clinical investigations as ISO 14155 or Post-market studies on the device
  • Develops relevant Literature search and review report template
  • Performs a systematic and comprehensive literature search from scientific databases based on research questions to meet the requirements of Annex I, GSPR [MDR] and SOTA/SOA, and prepares the literature search report for meeting the requirement of safety and performance of the device
  • Prepares literature search review report based on the review questions added in Literature search plan.

 

 

  • Develops Demonstration of Equivalence template based on MDCG guidance
  • Performs demonstration of equivalence
  • Informs about similar device details obtained from pieces of literature (if any)
  • Identification of equivalent device and provide the details for demonstration of equivalence (if claiming the equivalency)

 

  • As applicable, a contract must be signed between your company and the manufacturer of the equivalent device if your product is Class III or implantable or must have access to equivalent device data on an on-going basis, if any other classes (if applicable)

 

 

  • Develops appraisal of pertinent data template
  • Appraises the clinical data collected from the manufacturer as well as that from the literature search based on the criteria set in the Appraisal plan

 

 

  • Develops analysis of clinical data template
  • Performs qualitative analysis of the clinical data obtained from the literature as well as data retrieved from the manufacturer based on the essential requirements and corresponding GSPRs.

 

 

  • Develops CER template
  • Adds information on the CER template based on the summary of inputs from the clinical data provided by the manufacturer and/or the literature or from the Clinical investigation report from stage 1 to stage 3 meeting the GSPRs

 

 

PHASE 9

Post Market Surveillance and Vigilance Reporting

  • Develops or modifies the PMS procedure, if required

 

  • Analysis based of collected PMS data based on the reactive and proactive sources selected by the manufacturer.
  • Support PMS planning

 

  • PMS period confirmation
  • Supports in selecting the sources from our PMS Plan provided by us.

 

  • Guidance on Vigilance and CAPA if required.
  • Decision on whether PMCF study needs to be conducted based on the feedback and risk classification

 

  • Preparation of PMS report if Class I or PSUR if class IIa and above 
  • Vigilance Control Procedure as per MEDDEV 2.12-1 rev 8

 

  • Extent necessary support by following PMS plan scheduled for the period.

 

  • Collect PMS data based on the PMS sources chosen
  • Organize Customer Feedback

 

  • Organize Sales History and Sales volume data
  • Organize User Feedback in the drafted and provided.

 

  • Follow Vigilance and CAPAs if any required.
  • Review and approve PMS plan, other evidence and PMSR/PSUR

Post Market Clinical Follow-up 

  • Prepares procedure for PMCF, if required.

 

  • Prepares PMCF Plan & Evaluation Report templates based on the MDCG guidance
  • Support in selection of device for PMCF

 

  • Review the data entered in the PMCF plan to meet the chosen PMCF objective
  • Guides manufacturer to choose the suitable method as per the characteristics and type of medical devices.

 

  • Develops a well-defined PMCF study template and PMCF evaluation report template
  • Verifies the findings and the results based on the PMCF activity chosen by the manufacturer.

 

  • Analysis & Conclusion based on the study (by the evaluator) in the PMCF evaluation report.
  • Extend necessary support by following the PMCF plan

 

  • Follow PMCF period selected in line with the PMS
  • Identify List of Study Centres

 

  • Method of PMCF study based on Consultants Inputs
  • Clinical Investigation (If applicable) to be outsourced to third party agency

 

  • Review and approve PMCF plan, other evidence and PMCF Evaluation Report

PHASE 10

Notified Body Submission, Review and Site Audit and Issue of Certificate

  • Support identification of Notified Body

 

  • Application

 

  • Technical Documentation Submission

 

  • Answering to Notified Body Review comments

Team support and suggestions

  • Review draft Certificate

Review draft Certificate

 

Accept the electronic and hard copies of the CE Certificate