Registration fee: Rs.2,500/- (including GST)
Date: 22nd Nov. 2019
Boot Camp is an intensive interactive course directed towards participants who wish to expand or update their understanding of global regulations, and medical device development. There will also be a discussion to address new regulatory changes happening in India, EU and USA and its impact in Make In India.
At present, the Medical Device Industry in India is evolving at a much faster pace and since there is constant innovation and research work driving the entire ecosystem, the Medical Devices are becoming more affordable and accessible in the market. And also the startups are doing extremely well in terms of maintaining the standards and are slowly changing people's mindset in the Medical Community. Since Medical Device Industry keeps fluctuating all the time in terms of product acceptability and technological advancements, implementation plays a vital role. However, with the help of Doctors and Healthcare Institutions, these startups are aiding the best possible results and are turning every idea into a real time medical application.
The boot camp will focus on Regulatory Requirements, Changing Indian Clinical Trial Requirements, Chemical Characterization and Biocompatibility Studies planning
Who should attend
Attendees should have an understanding of Medical Device Regulatory Affair, Clinical Trial and keen interest to market the device in India or export to EU, USA.
This course is developed for all the medtech start-ups who are at design phase, Proof-of Concept phase, manufacturing or marketing phase. i) employees and management of medical device industry, ii) Faculty new to the discipline of medical device development and iii) those seeking more information to complement their regulatory, clinical, toxicological or marketing training.
Medical Device Regulatory Affair Requirements (India, EU, USA)
Impact of New Clinical Trial Rule, 2019 and Requirements to conduct the Proof-of-Concept
Impact Assessment & Requirements of Chemical Characterization and Toxicological Analysis in Raw-Material Selection
Understanding the New Requirements of Biocompatibility Studies as per ISO 10993-1:2018
Summary and Conclusions
Award of Certificates
Upon completion of the course, the participants should be able to:
- Become knowledgeable about the New Indian Medical Device Rule, 2017
- Know about the ISO 13485:2016 Quality Management System Requirements for Medical Device
- Know about the selection process of correct Notified Body
- Have basic understanding on the CE Certification Requirements as per EU MDR 2017/745 and EU IVDR 2017/746
- Know the basic aspects of 510k documentation, application and approval process
- Know about the New Indian Clinical Trial, 2019 requirements and its impact in performing the Proof-of Concept (PoC)
- Have a understanding on Chemical Characterization Planning and its impact assessment in Raw Material Selection
- Have basic understanding on the New Requirements of Biocompatibility Studies as per ISO 10993-1:2018
- Know about the selection process of Biocompatibility Partners
Boot Camp Co-Chairs
- Mr. Siddharth Jain, Chief Medical Device Regulatory Advisor, Symbiorph Clinical Trialogy
- Prof (Dr.) Bhaswat S. Chakraborty, External Professor, Institute of Pharmacy, Nirma University and Executive Scientific Advisor, Symbiorph Clinical Trialogy
- Dr. T. S. Kumaravel, Chairman, GLR Laboratories Pvt. Ltd.
- Mr. Shivkumar Vishwanathan, Director, GVS Cibatech Pvt. Ltd.
Prof (Dr.) Bhaswat S. Chakraborty, External Professor, Institute of Pharmacy, Nirma University and Executive Scientific Advisor, Symbiorph Clinical Trialogy