
Define medical devices and their regulation, including active, non-active, in vitro diagnostics, and software as a medical device, with India and EU regulatory pathways and career opportunities.
Explore how regulatory principles ensure medical device safety and risk management, from classification and approval under Indian regulations to post-market surveillance, complaint handling, and licensing for import/export.
Explore India's medical device regulatory pathway, including registration, licensing, form 40, and three-year certificate validity, with emphasis on costs, clinical trial considerations, and import and export responsibilities.
Explore levels of evidence in regulatory reviews for drugs and class three devices, and how safety, efficacy, and investigational new drug applications drive approval.
Identify how the FDA classifies medical devices by risk, with exemptions for low-risk trials and premarketing submissions via IDE, de novo, or humanitarian options, plus post-market surveillance.
Explore India's top 80 medical device companies, market growth, and regulatory pathways, revealing diverse job opportunities—especially in regulatory affairs—as the sector expands toward $15 billion by 2025.
Medical Devices:
An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.
Medical devices range from simple to sophisticated and there more than 10 000 types of medical devices available making proper selection appropriate to the needs of the population, the available infrastructure and clinical procedures very complicated.
The global need for access to effective, innovative, and affordable medical devices is a critical component of the United Nations Sustainable Development Goals, to ensure healthy lives and promote well-being for all at all ages and this course will take you through all of this.
Who can enroll?
· Students pursuing their Life Science / Biotechnology / Bioscience / BSc / BTech / MSc / MTech who aspire to work in the clinical research field.
o Frequently Asked Questions:
o What is the time limit to complete the course?
Unlimited access until you decides to complete the course. But once you have given your certification test, the course ends. If you fail in the test, you can revise the course again
o How do I evaluate myself?
Time to test all the knowledge you have gained. Take the test at the end of the course and evaluate yourself. Every Learning Course has a test at the end.
o How to get the certificate?
To avail, the certificate, take the test at the end of the course. Clearing the test (with a minimum of 50%) will earn you the certificate. The certificate can be downloading from our website. The certificate has a unique code by which anybody can verify the certificate on our website.
What Benefits are you going to get from this course?
o Lifetime validity
o Demonstration Videos
o Earn an Industry recognized Certificate.
o Hands-on Projects to practice various concepts & tools, evaluated by our lead trainer.
o You can access the session from anywhere without any hassle.
o Lifetime recording access
o Get weekly assignments & live projects to build confidence in applying the learning, to produce real results
o Hand-outs will be given to help you maximize the value of online sessions
o Beat the rising competition for enormous career options in the Technical sector.
o Best quality content which is latest and up-to-date with the industry standards
o Implement strategies - the super-secret way.
o The learning experience from experienced and certified Trainers.
o Increase TECHNICAL KNOWLEDGE to get in the industry after engineering with this amazing strategy.