This online medical device compliance training course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues.

It is also useful to industry veterans who need extra training on these topics and to clear basic concepts

+COURSE DETAILS:

+Program Name – Certificate Course in Medical Device Regulatory Affairs (Distance Learning)

+Duration – 03 Months

+Mode – Distance / e-Learning

*Fees – Rs 16,600/-

+ COURSE HIGHLIGHTS:

*Completely Online (From Admission to Examination)

*Self Paced program designed for Working professionals and students pursuing higher studies

* Includes Study materials (Hard Copy- Books) & e-Learning materials (PPT’s, MCQ’s, FAQ’s etc…)

* Online Interaction option with the Faculty

* Industry Accepted Course Curriculum

*Certificate on Course Completion

* Online Examination (MCQ Type)

* 100 % Placement Assistance & Career Guidance

+ TOPICS COVERED:

​- Introduction to Medical devices

– Classification

– Exports & Registration in US & EU

– 510 K & CE Marking Procedures

– Pre-market Approval

– Post Market Compliance

– Labeling of Medical Devices

– Quality Management Systems for Medical Devices

– ISO 13485:2016

+ FOR DETAILED INFORMATION:

Call us at: 9595750750 / 020 46704472

Mail us at: info@regulatoryinstitute.com