Technical file of an IVD product
The purpose of the project is to help students understand the requirements for the market clearance of devices on the market through the preparation of a technical file.
- Duration
- 12 weeks
- Content
- 18 hours
- Projects
- 2
- Mode
- Online
OverviewWhat you'll
What you'll
be able to do.
- The "In Vitro Diagnostics (IVD)" course provides a broad understanding of the skills required to get effectively involved in the following:
- IVD product development
- Validation testing guidelines
- IVD working environment
- Pre- and post-market regulations of various countries
- The course exposes the learners to the knowledge of the requirements to move an IVD product from concept to market launch with essential regulatory approvals.
- The course aims to equip individuals with a minimum and intermediate level of experience in the field of In Vitro Diagnostics.
- The learners can be from different sectors, including basic sciences, applied sciences, engineering backgrounds, and other related disciplines.
- They can enroll in this program to get a wider understanding of the IVD industry.
Curriculum12 modules,
12 modules,
built with industry.
01In Vitro Diagnostics
- Module 1 - Introduction of IVDW01
- Definition of Medical Device and IVD
- Scope of IVD
- Instruments
- Reagents
- Software
- Categorization
- Module 2 - Clinical Chemistry, Hematology, and MicrobiologyW02
- Introduction and Definition
- Application
- Working Principle
- Enzyme Substrate-Colorimetric
- Bio-Chemical Reaction
- Blood Cell Count
- Specimen: Blood, Serum, Plasma, Urine, and Other Body Fluids
- Microbial Culture
- Module 3 - Immunology and Molecular DiagnosticsW03
- Introduction and Definition
- Application
- Working Principle
- Immunology
- ELISA
- LFA
- FIA / FEIA
- CLIA
- MDx
- Turbidimetric
- Nucleic Acid Extraction
- RT-PCR
- qPCR
- Gene Sequencing
- Module 4 - Specimen Receptacles and ConsumablesW04
- Introduction and Definition
- Application
- Working Principle
- Blood Collection Tube
- Transport Medium
- Cuvette
- Sample Cups
- Module 5 - Regulatory and Statutory ComplianceW05
- Indian Regulatory Requirements (Indian MDR-2017)
- Product Specific Certification
- CE (IVDD-IVDR)
- WHO-PQ
- Country Registration
- Clinical Evaluation and Approval from National Accredited Laboratories
- Pollution Control Certification (Solid, Water, and Air)
- Health and Safety
- Fire Licence
- Module 6 - Instruments and SoftwareW06
- Introduction and Definition
- Application
- Self-Test (Home-Based Instruments)
- Professional Instruments
- Software Application
- Module 7 - Product Life Cycle-1W07
- Product Development (Assay, Instrument, and Software)
- Product Validation
- Analytical
- Clinical and Scientific Validation and Evaluation (Harmonized Standards and CLSI guidelines)
- Module 8 - Product Life Cycle-2W08
- Product Commercialization
- Post Market Surveillance
- Product Modification
- Product Discontinuation
- Module 9 - IVD Product Manufacturing and TestingW09
- Good Manufacturing Practice
- Quality Control Process (Incoming and FG Release)
- Good Laboratory Practice
- Module 10 - QMS-1W10
- Indian standard Requirements (Indian MDR-2017-Schedule 5)
- ISO 13485 and 9001
- 21-CFR-820
- Quality Policy
- Quality Objective
- CAPA
- IQA
- MRM
- Module 11 - QMS-2 W11
- Quality Policy
- Quality Objective
- Risk management
- CAPA
- IQA
- MRM
- PMS and Vigilance
- Advisory Notice and FSCA
- NCM
- Module 12 - National and Global Market Trend of IVDW12
- Indian IVD Market Size and Opportunities
- Global IVD Market Size and Opportunities
- Opportunities and Thread
- Next Generation of IVD
- NGS
- POCT
- Digitization of IVD
- Application of AI in IVD
- Multiplex Array
- Module 1 - Introduction of IVDW01
Industry projects2 projects
2 projects
you'll ship.
Our projects are designed by experts in the industry to reflect industry standards. By working through our projects, Learners will gain a practical understanding of what they will take on at a larger-scale in the industry. In total, there are 2 Projects that are available in this program.
Performance evaluation report for an IVD medical device
The purpose of this project is to help students understand the requirements of a performance evaluation plan, learn how to draft the contents required for regulatory submission, an…
FeeOne fee.
One fee.
Everything included.
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