Courses

Certification Course in Medical Device Quality Management System (75 days)

Course Module:

• Introduction to various medical device regulatory

• Introduction to ISO 13485:2016 QMS

• Maintenance of documentation at a Medical Device Manufacturing Unit...

• Risk Management & Risk Analysis - ISO 14971

• Device Master File Preparation

• Document preparation for Regulatory Submissions of Medical Devices...

• ISO 13485:2016 Internal Auditor Training

Course Highlights:

• Training by IRCA-CQI Approved Lead Auditors
• Internship at PREMIUM Consulting Company, M/s. IQZYME MEDTECH PVT. LTD...
• Hands-on experience in QMS and Technical Documentation...
• Lectures by Industry Veterans
• Factory Visit to Medical Device Manufacturing Units
• Placement Assistance
• Issuance of ISO 13485:2016 Internal Auditor Training Certificate
• Annual Membership in Medical Device Proficiency Program (Free access to monthly training sessions/webinars with respect to the Indian Medical Devices Market)

Certification Course in QMS Documentation of Medical Devices (45 days)

Course Module:

• Introduction to various medical device regulatory bodies

• Introduction to ISO 13485-2016 QMS

• Maintenance of documentation at a Medical Device Manufacturing Unit...

• Maintenance of documentation at a Medical Device Manufacturing Unit as per Indian Medical Devices Rules, 2017 (Training with respect to drafting of SOP’s, Records Template, Batch Manufacturing Records, QC Test Reports etc.)

Course Highlights:

• Training by IRCA-CQI Approved Lead Auditors
• Internship at PREMIUM Consulting Company, M/s. IQZYME MEDTECH PVT. LTD...
• Factory Visit to Medical Device Manufacturing Units
• Placement Assistance

ISO 13485:2016 Internal Auditor Course. (available at B4 edtech training campus and/or Client facility ). (3 days)

IRCA-CQI Approved ISO 13485:2016 Lead Auditor Course (available at B4 Edtech training campus and/or Client facility). (5 days)

Certification Course in Biomedical Equipment Installation & Servicing (40 days)

Course Module:

• Introduction to Biomedical Equipment

• Biomedical Equipment Installation

• Preventive Maintenance

• Troubleshooting and Repair

• Regulatory Compliance

• Quality Management in Biomedical Equipment Servicing

• Emerging Technologies and Trends

Course Highlights:

• Hands-on training in installation, maintenance, and troubleshooting of biomedical equipment.
• Expert guidance from industry professionals with extensive experience
• Practical skills development through simulations and real-world scenarios.
• Certification upon successful completion, enhancing career prospects in healthcare technology.

Certification Course in IVD Medical Devices Installation & Servicing (30 days)

Course Overview: This 30-day intensive program is designed to equip participants with the skills and knowledge required for the proficient installation, maintenance, and servicing of In Vitro Diagnostic (IVD) medical devices used in healthcare settings. The course combines theoretical knowledge with hands-on experience under the guidance of industry experts.

Course Module:

• Introduction to IVD Medical Devices

• IVD Medical Devices Installation

• Preventive Maintenance of IVD Devices

• Regulatory Compliance for IVD Devices

• Quality Management in IVD Device Servicing

• Emerging Technologies and Trends in IVD Devices

Course Highlights:

• Hands-on Training: Practical experience with installation, maintenance, and troubleshooting of IVD devices.
• Expert Guidance: Learn from seasoned professionals with extensive experience in the IVD field.
• Practical Skills Development: Engage in real-world scenarios and case studies to enhance your problemsolving skills.
• Certification: Receive a certification upon successful completion, boosting your credentials in the IVD medical devices sector.

Certification Course to become expert in single point department (IVD ,Patient care , USD, Dental , Critical care , Non active medical device and consumables ) (60 days)

Course Module:

• Introduction to the Chosen Department

• Equipment Installation

• Pre-installation planning and site assessment

• Detailed installation procedures specific to the department

• Safety protocols and compliance during installation

• Preventive Maintenance

• Troubleshooting and Repair

• Regulatory Compliance

• Quality Management

• Emerging Technologies and Trends

• Specialization Options:

1. In Vitro Diagnostics (IVD)

• Focus on diagnostic instruments and laboratory equipment

• Installation, calibration, and maintenance of IVD devices

2. Patient Care

• Emphasis on patient monitoring systems and bedside equipment

• Ensuring the reliability and safety of patient care devices

3. Ultrasound Devices (USD)

• Specialization in ultrasound imaging equipment

• Techniques for maintaining image quality and equipment functionality

4. Dental Equipment

• Focus on dental chairs, imaging systems, and handpieces

• Ensuring compliance with dental care standards and protocols

5. Critical Care Equipment

• Emphasis on ventilators, infusion pumps, and monitoring systems

• Ensuring functionality and reliability in critical care settings

6. Non-active Medical Devices

• Specialization in devices without electronic components (e.g., surgical instruments, orthopedic implants)

• Maintenance and sterilization procedures

7. Medical Consumables

• Focus on disposable medical products (e.g., syringes, gloves, catheters)

• Ensuring quality and compliance with safety standards

Course Highlights:

• Hands-on Training: Practical experience with installation, maintenance, and troubleshooting specific to the chosen department.
• Expert Guidance: Learn from industry professionals with extensive experience in your area of specialization.
• Practical Skills Development: Engage in real-world scenarios and case studies to enhance your problem-solving skills.
• Certification: Receive a certification upon successful completion, enhancing your professional credentials.