Regulatory processes for medical devices
Get an in-depth understanding of regulatory processes for medical devices.
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Syllabus
This course is full of best-in-class content by leading faculty and industry experts in the form of videos and projects
Course Overview
- The students will gain a thorough knowledge on
- Medical device classification, registration, licensing, and timelines
- Approvals from central or state authorities for product release
- Filling an application for a medical device product launch
- The course also details the process of medical device registration, approvals, fees, and timelines for all processes that are required for medical devices or in-vitro diagnostic devices manufacturing, distribution, or importing.
Course Syllabus
On a daily basis we talk to companies in the likes of Tata Elxsi and Mahindra to fine tune our curriculum.
Module 1 - Overview of Indian MDR2017 Part I
- Introduction
- Preliminary
- Regulation of Medical Device
- Authorities, Officers, and Bodies
- Manufacture of Medical Devices for Sale and Distribution
- Import of Medical Devices
- Labeling of Medical Devices
Module 2 - Overview of Indian MDR2017 Part II
- Clinical Investigation of Medical Devices and Clinical Performance Evaluation of New In Vitro Diagnostic Medical Devices
- Import or Manufacture a Medical Device that does not Have a Predicate Device
- Duties of Medical Device Officer, Medical Device Testing Officer, and Notified Bodies
- Registration of Laboratory for Carrying out Test or Evaluation
- Sale of Medical Devices
Module 3 - Schedules of MDR - Part 1
- First Schedule - Parameters for Classification of
- Medical Devices
- In Vitro Diagnostic Medical Devices
- Second Schedule - Fee Payable for License, Permission, and Registration Certificate
- Third Schedule - Documents Required for Registration of Notified Body, its Duties, and Functions.
Module 4 - Schedules of MDR - Part 2
- Fourth Schedule
- Documents required for Grant of License to Manufacture for Sale or for Distribution or Import
Module 5 - Schedule - CE Marking
- Fifth Schedule
- Quality Management System for Medical Devices
- In vitro Diagnostic Medical Devices
Module 6 - Overview of the Two Important Global Regulations - EU MDR and US FDA
- Sixth Schedule - Post Approval Change
- Seventh Schedule - Requirements for permission to import or manufacture an investigational medical device for conducting a clinical investigation
- Eighth Schedule - Exemptions
Module 7 - Indian MDR,2017 vs EU regulations (MDR-2017/745 & IVDR-2017/746)
- Introduction about EU MDR-2017/745 & IVDR - 2017/746
- How Indian Medical Device Rules, 2017 will Interlink with MDR - 2017/745 & IVDR - 2017/746
Module 8 - Other Countries Regulation which Interlinked with Indian Medical Device Rules
- WHO-PQ (Prequalification)
- US-FDA
- TGA Medical Device Regulations
Module 9 - Standards - 1
- Purpose of Standards and their benefits
- Elements of Quality Infrastructure & Customer focus
- Basic Structure of Standards
- Types of Standards
- National Standards Bodies and International Organization for Standardization (ISO)
- Standards Development Process
- Harmonization of Standards
Module 10 - Standards - 2
- Applicable Standards for Medical Devices/Equipment
- Brief Introduction to Other Standards like
- IEC 60601-1
- ISO 16142-1
- ISO 16142-2
- Key Aspects of ISO 13485: 2016
Module 11 - Standards - 3
- Key Aspects of ISO 13485: 2016 - Implementation
- Quality Management Systems
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis, and Improvement
Module 12 - Certification - 1
- Abbreviations and Definitions
- What is Certification?
- Why Certification?
- Who Provides Certification Services?
- Selection of Certification Body
- Certification Audit
Module 13 - Certification - 2
- MS Certification Process
- MS Certification Maintenance Process
- MS Recertification Process
Module 14 - Accreditation
- Why Accreditation?
- Accreditation vs Certification
- Accreditation Standards
- National Accreditation Framework - India
- International Accreditation Framework
- Global Acceptance Mechanism
- Accreditation Process in Brief
- Accreditation Traceability
Our courses have been designed by industry experts to help students achieve their dream careers
Industry Projects
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.
Preparation of a Dummy Design Docket by Schedule V of the MDR URS
In this project, students will have to prepare a dummy design docket as required by schedule V of the MDR URS.
Students will be asked to do the following:
- Deliver the learning of regulatory policies requiring information about the device master file.
- Understand the requirements of market clearance of devices in the Indian market.
- Provide requirements on product description including risk analysis related to design and manufacturing processes.
- Provide characteristics of verification and validation – Analytical and clinical performance reports.
Clinical Investigation Plan
This project deals with the clinical investigation plan's identification, overall synopsis, and justification.
In this project, students will be asked to
- Deliver the learning of policies involved in the clinical investigation plan, its justification, and conducting the investigation.
- Visualize and frame the risks and benefits of the investigational medical device and clinical investigation of its objectives and hypotheses.
- Design statistical considerations data management relevant to clinical investigation
Our courses have been designed by industry experts to help students achieve their dream careers
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Flexible Pricing
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INR 40,000
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Instructors profiles
Our courses are designed by leading academicians and experienced industry professionals.
1 industry expert
Our instructors are industry experts along with a passion to teach.
14 years in the experience range
Instructors with 14 years extensive industry experience.
Areas of expertise
- Medical device
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