The course is ideal for usfda medical device regulation like 510k registeration pre market approval and labelling of medical device.
Medical device courses india.
Star radiance institute of medical devices.
Import and export of medical devices.
We offer a comprehensive range of medical device training courses covering a variety of formats including online public or if you prefer to have a group of employees attend a course together choose inhouse it s your choice.
Online training in medical device regulation in india and worldwide.
Medical devices rules 2017 g s r.
This global medical device regulatory affairs professional certification program is an online program which guides the student through a global medical device regulations overview.
78 e dated the 31st january 2017 are published and are mandatory with effect from 1st january 2018.
Jude medical stryker boston scientific bpl healthcare india sushrut.
Recent amendments made in the rules by incorporating specific rules i e.
Courses can be customised to your requirements.
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.
These rules provided requirements for import manufacture clinical investigation medical device and in vitro diagnostics.
It discusses how iso13485 2003 the iso standard relates to the industry of medical devices details the regulatory ex.
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.