This document discusses regulatory affairs for medical devices. It explains that regulatory affairs professionals help medical companies bring products to market by managing regulatory activities. The course prepares students to understand regulations around developing, testing, and commercializing medical devices from agencies like the FDA and in the EU. It covers topics like classifying devices, obtaining approvals, inspections, compliance, quality management systems, and labeling.

1. Medical Device
Regulatory
Affairs
What is Medical Device Regulatory Affairs
Ever changing laws and regulations are
driving demand for regulatory affairs
professionals who can help companies
bring medical product to market. The
Regulatory affairs for Drugs, Biologics,
and Medical Devices prepareyou to
manage regulatory activites and is design
to deepen your understanding of current
regulations in the development and
commercialization of drugs, biologics,
and medical device products.

2.  This course is specifically
focused on the law, regulations
and policies set by the
regulatory bodies for the pre-
market approval, manufacture
and post-marketing compliance
of medical devices. (US, EU)
 The course content is designed
to provide an in-depth
understanding of the ways to
obtain the agency approval
 It also provides FDA strategies
towards inspections of
manufacturing sites, and
compliance actions that may
result from these inspections
SCOPE

3.  What are Medical Devices?
 Classification of Medical
devices - USA- Europe- India
 Exporting & Registeration of
Medical devices - USA-
Europe- India
 510k Submission
 CE Marking
 QMS & ISO for Medical
Devices
 Labelling of Medical Devices
GET TO LEARN

4.  FOR ADMISSION PLEASE CONTACT:
Call us at: 9595 750 750 / 020 4670 4472
Mail us at info@regulatoryinstitute.com
"GIRA is an
ISO 9001:2008
Certified Institute"
"It is Accredited by
Joint Accreditation system
Australia and New Zealand
(JASANZ)"