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.
Biomedical · Course
Regulatory Process, Standards and Certifications for Medical Devices
Learn the ins and outs of Regulatory Processes, Standards and Certifications for Medical Devices.
- Duration
- 14 weeks
- Content
- 23 hours
- Projects
- 4
- Mode
- Online
OverviewWhat you'll
What you'll
be able to do.
- This course explains the Indian Medical Device regulatory system and its structure.
- This course will give you an overview of how a medical device is created from the bench to the market.
- The course explains the process of medical device registration, approvals, and fees, as well as the importance of compliance (especially ISO 13485), certification, accreditation, international recognition, etc.
- This program compares and contrasts the Indian licensing process and regulations with those of various other countries.
Curriculum14 modules,
14 modules,
built with industry.
01Regulatory Process, Standards and Certifications for Medical Devices
- Module 1 - Overview of Indian MDR2017 Part IW01
- Introduction
- Preliminary
- Regulation of Medical Devices
- Authorities, Officers, Bodies
- Manufacture of Medical Devices for Sale and Distribution
- Import of Medical Devices
- Labelling of Medical Devices
- Module 2 - Overview of Indian MDR2017 Part IIW02
- Clinical Investigation of Medical Devices and Clinical Performance Evaluation of New InVitro 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 1W03
- 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
- First Schedule - Parameters for Classification of
- Module 4 - Schedules of MDR - Part 2W04
- Fourth Schedule
- Documents Required for Grant of License to Manufacture for Sale, Distribution, or Import
- Fourth Schedule
- Module 5 - Schedule - CE Marking W05
- Fifth Schedule
- Quality Management System for Medical Devices
- In Vitro Diagnostic Medical Devices
- Fifth Schedule
- Module 6 - Overview of the two important Global regulations - EU MDR and US FDAW06
- 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)W07
- 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 RulesW08
- WHO-PQ (Prequalification)
- US-FDA
- TGA Medical Device Regulations
- Module 9 - Standards - 1W09
- Purpose of Standards and their Benefits
- Elements of Quality Infrastructure and 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 - 2W10
- 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 - 3W11
- Key Aspects of ISO 13485: 2016 - Implementation
- Quality Management Systems
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analysis, and Improvement
- Key Aspects of ISO 13485: 2016 - Implementation
- Module 12 - Certification - 1W12
- Abbreviations and Definitions
- What is Certification?
- Why Certification?
- Who provides Certification Services?
- Selection of Certification Body
- Certification Audit
- Module 13 - Certification - 2W13
- MS Certification Process
- MS Certification Maintenance Process
- MS Recertification Process
- Module 14 - AccreditationW14
- Why Accreditation?
- Accreditation vs. Certification
- Accreditation Standards
- National Accreditation Framework - India
- International Accreditation Framework
- Global Acceptance Mechanism
- Accreditation Process in Brief
- Accreditation Traceability
- Module 1 - Overview of Indian MDR2017 Part IW01
Industry projects4 projects
4 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 4 Projects that are available in this program.
Clinical Investigation Plan for Medical Device
In this project, learners will be asked to design statistical considerations and data management relevant to clinical investigation.
Quality Evaluation Report
In this project, students must develop a detailed questionnaire to evaluate the quality of products and services provided by medical device manufacturing companies. This serves as …
Risk Assessment in a Medical Device Manufacturing Company
In this project, the students have to assume that they are working in a medical device manufacturing company and prepare a detailed risk assessment for the selected device to cover…
FeeOne fee.
One fee.
Everything included.
Become job ready with our comprehensive industry focused curriculum for freshers & early career professionals
Premium
₹40,000
Inclusive of all charges- 1 Year Access
- Personalized Page
- Live Individual & Group Sessions
- Personalized & Hands-On
- Job-Oriented Industry Relevant Curriculum
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