Medical devices rules 2017 g s r.
Medical device courses in india.
Courses can be customised to your requirements.
Is the largest consumer of medical devices and leads the world in the production of medical devices.
Online training in medical device regulation in india and worldwide.
These rules provided requirements for import manufacture clinical investigation medical device and in vitro diagnostics.
Star radiance institute of medical devices.
We also offer a wide range of specialist courses.
78 e dated the 31st january 2017 are published and are mandatory with effect from 1st january 2018.
No matter the size of your organisation sgs s medical device testing certification audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals.
We have the privilege of serving the health care industry in india for more than 32 years with world class medical devices in the diverse fields.
Our expert tutors are industry leaders who have trained over 70 of the top 100 medical device companies globally so.
The course is ideal for usfda medical device regulation like 510k registeration pre market approval and labelling of medical device.
Learn how to design and develop medical devices to international quality standards such as iso 13485 how to meet and keep ahead of medical device directive regulatory requirements and gain knowledge of the ce marking process.
Executive diploma in medical device management is a fast track course which endows theoretical as well as practical knowledge to the candidate required to sustain successfully in industry.
Has a medical device market valued at more than 100 billion in 2008 roughly 42 percent of the world s total.
Import and export of medical devices.
To fill the regulatory vacuum in quality certification space for medical devices in the country the association of indian medical device industry aimed in collaboration with the quality council of india qci and the national accreditation board for certification bodies nabcb is rolling out a voluntary quality certification scheme for medical devices.
Professional and industry oriented training courses such as medical device management by igmpi open doors for entry into the industry.
Recent amendments made in the rules by incorporating specific rules i e.